72762 Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices 

technical assistance is needed to help 

recipients improve their program 

implementation if necessary. In 

addition, the findings continue to allow 

CDC to determine the potential impact 

of currently recommended strategies 

and make changes to those 

recommendations if necessary. DASH 

was able to refine and target the 

technical assistance provided to 

recipient agencies to better ensure they 

completed their work plans and spent 

funds according to the original Notice of 

Funding Opportunity. The reporting 

template will include sections on the 

following topics: sexual health 

education (SHE), sexual health services 

(SHS), safe and supportive 

environments (SSE) required and 

additional activities. No personally 

identifiable information will be 

collected. 

The estimated burden per response 

ranges from eight hours for Component 

1 to 14 hours for Component 2. 

Recipients will complete the reporting 

templates every six months and the 

work plan templates once a year under 

this approval. Annualizing the 

collection over one year results in an 

estimated annualized burden of 3,320 

burden hours for respondents. There are 

no costs to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Surveillance Recipients (Program 

Managers).

Promoting Adolescent Health 

through School-Based HIV/STD 

Prevention Component 1 Reporting Template and Work Plan.

80 3 8 1,920 

Local education agency HIV prevention recipients (Program Managers).Promoting Adolescent Health 

through School-Based HIV/STD 

Prevention Component 2 Reporting Template and Work Plans (required programmatic activities 

work plan and professional development work plan).

25 4 14 1,400 

Total ........................................... ........................................................... ........................ ........................ ........................ 3,320 

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. 2023–23340 Filed 10–20–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-24–1289] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Sealant 

Efficiency Assessment for Locals and 

States (SEALS)’’ to the Office of 

Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on June 5, 

2023 to obtain comments from the 

public and affected agencies. CDC did 

not receive comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) 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; 

(b) Evaluate the accuracy of the 

agencies 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; 

(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; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

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. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Sealant Efficiency Assessment for 

Locals and States (SEALS) (OMB 

Control No. 0920–1289)— 

Reinstatement—National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

By age 19, 67% of U.S. adolescents 

living in poverty have experienced tooth 

decay and 27% have at least one 

decayed tooth needing treatment. 

School sealant programs provide dental 

sealants, which protect against 80% of 

cavities for two years, and continue to 

protect against 50% of cavities for up to 


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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices 72763 

four years. CDC requests information 

from states regarding children’s cavity 

risk, one-year sealant retention rate, 

sealant program services delivered, and 

school sealant program cost and 

quantity of resources used at each 

school event. This data will allow CDC 

and states to monitor the performance 

and efficiency of their school sealant 

programs, which will improve and 

extend program delivery to more 

children. 

CDC requests OMB approval for a 

Reinstatement of a previously approved 

data collection. The total estimated 

annualized burden hours requested are 

1,388. There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

State Sealant Administrator .................................. Add Program and Add User ................................. 18 1 45/60 

SSP Local Administrator ....................................... Add User and Add School ................................... 162 1 43/60 

SSP Local Administrator ....................................... Program Options and Cost Options ..................... 162 1 46/60 

SSP Local Administrator ....................................... Add Event ............................................................. 162 20 21/60 

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. 2023–23339 Filed 10–20–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4488] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2024 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the fee rates and payment 

procedures for fiscal year (FY) 2024 

animal drug user fees. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Animal Drug 

User Fee Amendments of 2023 (ADUFA 

V), authorizes FDA to collect user fees 

for certain animal drug applications and 

supplemental animal drug applications, 

for certain animal drug products, for 

certain establishments where such 

products are made, and for certain 

sponsors of such animal drug 

applications and/or investigational 

animal drug submissions. This notice 

establishes the fee rates for FY 2024. 

DATES: The application fee rates are 

effective for applications submitted on 

or after October 1, 2023, and will remain 

in effect through September 30, 2024. 

FOR FURTHER INFORMATION CONTACT: Visit 

FDA’s website at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalDrug

UserFeeActADUFA/default.htm or 

contact Lisa Kable, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6888, 

Lisa.Kable@fda.hhs.gov. For general 

questions, you may also email FDA’s 

Center for Veterinary Medicine (CVM) 

at: cvmadufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 740 of the FD&C Act (21 

U.S.C. 379j–12), as amended by ADUFA 

V, establishes four different types of 

user fees: (1) fees for certain types of 

animal drug applications and 

supplemental animal drug applications; 

(2) annual fees for certain animal drug 

products; (3) annual fees for certain 

establishments where such products are 

made; and (4) annual fees for certain 

sponsors of animal drug applications 

and/or investigational animal drug 

submissions (21 U.S.C. 379j–12(a)). 

When certain conditions are met, FDA 

will waive or reduce fees (21 U.S.C. 

379j–12(d)). 

For FYs 2024 through 2028, the FD&C 

Act establishes the base revenue amount 

for each fiscal year (21 U.S.C. 379j– 

12(b)(1)). Beginning in FY 2025, the 

base revenue amount is subject to 

adjustment for inflation and workload 

(21 U.S.C. 379j–12(c)(2) and (3)). Also 

beginning in FY 2025, ADUFA V 

provides for an operating reserve 

adjustment to allow FDA to adjust the 

fee revenue amount to maintain a 

specified operating reserve of carryover 

user fees (21 U.S.C. 379j–12(c)(4)). FDA 

may increase the fee revenue amount to 

maintain a 12-week minimum. If FDA 

has an excess operating reserve, FDA 

will decrease the fee revenue amount so 

that FDA has 22 weeks of operating 

reserve for FY 2025, 20 weeks for FY 

2026, 18 weeks for FY 2027, and 16 

weeks for FY 2028. 

Fees for applications, establishments, 

products, and sponsors are to be 

established each year by FDA so that the 

percentages of the total revenue that are 

derived from each type of user fee will 

be as follows: (1) revenue from 

application fees shall be 20 percent of 

total fee revenue; (2) revenue from 

product fees shall be 27 percent of total 

fee revenue; (3) revenue from 

establishment fees shall be 26 percent of 

total fee revenue; and (4) revenue from 

sponsor fees shall be 27 percent of total 

fee revenue (21 U.S.C. 

379jndash;12(b)(2)). The fee revenue 

amount for FY 2024 is $33,500,000 (21 

U.S.C. 379j–12(b)(1)). The target revenue 

amounts for each fee category for FY 

2024 are as follows: for application fees, 

the target revenue amount is $6,700,000; 

for product fees, the target revenue 

amount is $9,045,000; for establishment 

fees, the target revenue amount is 

$8,710,000; and for sponsor fees, the 

target revenue amount is $9,045,000. 

For FY 2024, the animal drug user fee 

rates are: $683,673 for an animal drug 

application; $341,837 for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required, for an animal drug application 

subject to the criteria set forth in section 

512(d)(4) of the FD&C Act (21 U.S.C. 

360b(d)(4)), and for an application for 

conditional approval under section 571 

of the FD&C Act (21 U.S.C. 360ccc) for 

which an animal drug application 

submitted under section 512(b)(1) of the 

FD&C Act has been previously approved 

under section 512(d)(1) of the FD&C Act 

for another intended use; $12,459 for 

the annual product fee; $174,200 for the 

annual establishment fee; and $153,305 

for the annual sponsor fee. FDA will 

issue invoices for FY 2024 product, 

establishment, and sponsor fees by 

December 31, 2023, and payment will 

be due by January 31, 2024. The 

application fee rates are effective for 

applications submitted on or after 

October 1, 2023, and will remain in 

effect through September 30, 2024. 


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