2024-03884. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Project Confianza to Identify Medical Mistrust Drivers among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men (HLMSM). The data collection is designed to identify the root causes of medical mistrust and opportunities to implement interventions that can make HIV-related services trusted and acceptable for HLMSM to increase access to, and utilization of, HIV prevention and care services, as well as contribute toward achieving Ending the HIV Epidemic in the U.S. (EHE) goals and National HIV Strategic Plan health disparities goals.

DATES:

CDC must receive written comments on or before April 29, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC–2024–0012 by either of the following methods:

□ Federal eRulemaking Portal:www.regulations.gov. Follow the instructions for submitting comments.

□ Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

Proposed Project

Project Confianza to Identify Medical Mistrust Drivers among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men (HLMSM)—New—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

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.