14504 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 

Background and Brief Description 

Although the HIV diagnosis rate 

among Hispanic/Latino Americans (H/ 

L) has decreased in the United States 

(from 17.6/100,000 in 2014 to 11.0/ 

100,000 in 2019), H/L continue to be 

disproportionately affected by HIV. H/L 

account for 18.7% of the US population 

and in 2019 they accounted for 29% of 

new HIV diagnoses, the majority (85%) 

of which were among H/L gay, bisexual 

and other men who have sex with men 

(HLMSM). Medical mistrust (MM) is a 

social determinant of health associated 

with HIV disparities (e.g., low PrEP 

willingness and adherence) among 

HLMSM that prevents and delays access 

and engagement in HIV prevention and 

care services (e.g., PrEP, ART). To date, 

most MM studies in the United States 

have focused on Black/African 

American persons. The few studies that 

have examined MM among H/L are 

mostly in non-HIV fields (e.g., 

reproductive health and chronic 

diseases, such as cancer screening). The 

literature highlights the need for 

research about MM among HLMSM. 

Because its root causes in this priority 

group are unknown, the goals of this 

collection are to understand pathways 

that lead to MM in HLMSM, and to 

capture variations in MM drivers among 

different H/L subgroups (e.g., 

Indigenous, Mexican, Puerto Rican, 

Salvadoran, Columbian). Methods used 

to collect data during this project 

include (1) In-depth interviews, focus 

groups, and quantitative surveys with 

HLMSM and (2) key informant 

interviews and focus groups with health 

care providers and H/L leaders/ 

gatekeepers. Projects collecting 

information under this request should: 

(1) identify the root causes of MM and 

opportunities to implement 

interventions that can make HIV-related 

services trusted and acceptable for 

HLMSM to help increase HLMSM 

access to, and utilization of, HIV 

prevention and care services; (2) 

contribute toward achieving Ending the 

HIV Epidemic in the U.S. (EHE) goals; 

and (3) respond to the National HIV 

Strategic Plan health disparities goals. 

CDC awarded a research cooperative 

agreement to three academic institutions 

(Johns Hopkins University [JHU]; the 

University of California, San Francisco 

[UCSF]; and Wake Forest University 

[WFU]) through a Notice of Funding 

Opportunity (NOFO) PS23–006. The 

total estimated annualized burden hours 

requested are 2,580. There is no cost to 

respondents other than their time to 

participate. 

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 

hours 

HLMSM ............................................. In-Depth Interview Screener (JHU) .. 66 1 10/60 11 

HLMSM ............................................. In-Depth Interview Guide (JHU) ....... 60 1 75/60 75 

HLMSM ............................................. Eligibility Questionnaire (WFU) ........ 70 1 5/60 6 

HLMSM ............................................. Demographic Questionnaire (WFU) 60 1 15/60 15 

HLMSM ............................................. In-Depth Interview Guide (WFU) ..... 60 1 1.5 90 

HLMSM ............................................. In-Depth Interview Screener (UCSF) 48 1 10/60 8 

HLMSM ............................................. In-Depth Interview Guide (UCSF) .... 40 1 45/60 30 

HLMSM ............................................. Focus Group Interview Screener 

(JHU).

55 1 10/60 9 

HLMSM ............................................. Focus Group Interview Guide (JHU) 50 1 75/60 63 

Key Informants (Service Providers 

and Community Leaders).

Focus Group Interview Screener 

(JHU).

55 1 10/60 9 

Key Informants .................................. Focus Group Interview Guide (JHU) 50 1 75/60 63 

Key Informants .................................. In-Depth Interview Screener (JHU) .. 55 1 10/60 9 

Key Informants .................................. In-Depth Interview Guide (JHU) ....... 50 1 75/60 63 

Key Informants .................................. Demographic Questionnaire (WFU) 30 1 10/60 5 

Key Informants .................................. In-Depth Interview Guide (WFU) ..... 30 1 1.5 45 

Key Informants .................................. In-Depth Interview Screener (UCSF) 12 1 10/60 2 

Key informants .................................. In-Depth Interview Guide (UCSF) .... 10 1 1 10 

HLMSM ............................................. Cross-Sectional Survey Screener 

(JHU).

1,788 1 10/60 298 

HLMSM ............................................. Cross-Sectional Survey (JHU) ......... 1,625 1 1 1,625 

HLMSM ............................................. Questionnaire Screener (UCSF) ...... 144 1 10/60 24 

HLMSM ............................................. Questionnaire (UCSF) ...................... 120 1 1 120 

Total ........................................... ........................................................... ........................ ........................ ........................ 2,580 

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. 2024–03884 Filed 2–26–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Tribal Child 

Support Enforcement Direct Funding 

Requests: (Office of Management and 

Budget #0970–0218) 

AGENCY: Office of Child Support 

Services, Administration for Children 

and Families, United States Department 

of Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Child Support 

Services (OCSS), Administration for 

Children and Families (ACF) is 

requesting to extend approval of 

revisions to an approved information 

collection the Tribal Child Support 

Enforcement Direct Funding Requests 

(Office of Management and Budget 

(OMB) #0970–0218). These revisions 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 14505 

were approved under an emergency 

approval for 6-months and included a 

new requirement for Tribes or Tribal 

organizations to provide that charging 

fees and recovering costs will not be 

permitted. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

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. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The final rule within 45 

CFR part 309, published in the Federal 

Register on March 30, 2004 at 69 FR 

16638, contains a regulatory reporting 

requirement that, in order to receive 

funding for a Tribal IV–D program, a 

Tribe or Tribal organization must 

submit a plan describing how the Tribe 

or Tribal organization meets or plans to 

meet the objectives of section 455(f) of 

the Social Security Act, including 

establishing paternity; establishing, 

modifying, and enforcing support 

orders; and locating noncustodial 

parents. The plan is required for all 

Tribes requesting funding; however, 

once a Tribe has met the requirements 

to operate a comprehensive program, a 

new plan is not required annually 

unless a Tribe makes changes to its title 

IV–D program. If a Tribe or Tribal 

organization intends to make any 

substantial or material changes, a Tribal 

IV–D plan amendment must be 

submitted for approval. Tribes and 

Tribal organizations must have an 

approved plan and submit any required 

plan amendments in order to receive 

funding to operate a Tribal IV–D 

program. Through an emergency 

approval request, OCSS included a new 

requirement for Tribes and Tribal 

organizations to provide that charging 

fees and recovering costs will not be 

permitted. This is due to the Final Rule 

on the Elimination of the Non-Federal 

Share published on February 12, 2024 

(see 89 FR 9784). Tribes and Tribal 

organizations that charge fees and 

recover cost must submit a plan 

amendment demonstrating compliance 

with the proposed new requirement, in 

accordance with 45 CFR 309.35(d). This 

is a one-time submission. Only three 

Tribal child support programs report 

data on the collection of fees and 

recovered costs. This request is to 

extend approval with no changes. 

Respondents: Tribes and Tribal 

Organizations. 

Burden Estimates 

The following burden estimates 

include new burden associated with the 

change in requirement, as well as 

existing burden under OMB #: 0970– 

0218. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

(over three 

years) 

Burden hours 

per response 

Total 

burden hours 

(over three 

years) 

Annual 

burden 

hours 

45 CFR 309—New Plan .................................................... 10 3 480 14,400 4,800 

45 CFR 309—Plan Amendment ........................................ 60 * 2 105 18,900 6,300 

45 CFR 309—Plan Amendment—Charging fees and recovering .......................................................................... 3 1 3 9 3 

Estimated Burden Hours and Costs ........................... ........................ .......................... ........................ 33,309 11,103 

* This estimate is based on an average number of about 2 amendments submitted per year per Tribe, but that does vary annually and by 

Tribe. 

Authority: Title IV–D of the Social 

Security Act; 45 CFR 309. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03968 Filed 2–26–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2217] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Rybrevant 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Rybrevant and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by April 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 26, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. eastern time at the end of 

April 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 


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