Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-26-1423; Docket No. CDC-2026-1190]

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Expanding PrEP in Communities of Color (EPICC). This project is designed to facilitate preexposure prophylaxis (PrEP) shared decision making, train providers on the use of Evidence Based Tools (EBT), and evaluate the impact within a longitudinal cohort.

DATES:

CDC must receive written comments on or before September 4, 2026.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2026-1190 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: 404-639-7118; Email:

omb@cdc.gov.

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

Expanding PrEP in Communities of Color (EPICC) (OMB Control No. 0920-1423, Exp. 12/31/2026)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Expanding PrEP in Communities of Color (EPICC) project proposes to: (1) adapt and implement existing Evidence Based Tools (EBTs) to facilitate preexposure prophylaxis (PrEP) shared decision making (SDM); (2) train providers on the use of EBT; and (3) evaluate the impact within a longitudinal cohort of racially and geographically diverse young men who have sex with men (YMSM) (ages 18-39). We refer to this combination of interventions as the EPICC+ intervention package, which includes provider training, EBT for providers, and a mobile app-based platform (EPICC+ app) to support ongoing participant engagement and monitoring, as well as to provide additional adherence support. This study will be carried out in seven clinics located in New York City, NY; Philadelphia, PA; Charlotte, NC; Raleigh, NC; Tuscaloosa, AL; Tampa, FL; and Houston, TX. This study will consist of three distinct aims (Aim 1, 2a, and 2b) to adapt and implement the EBT and materials.

Aim 1 will include 30 health care providers from the seven clinic sites, all involved in the direct delivery of PrEP services. Providers may include but are not limited to medical doctors, nurses, adherence counselors, pharmacists, and social workers. Health providers will be recruited via staff emails. Aim 2a participants will include 400 YMSM ages 18-39, inclusive, with an active prescription for PrEP and receiving care at one of the seven participating study sites, providing a mailing address within the 50 states where packages can be received; have daily smartphone access; and be fluent in written/spoken English or Spanish. We will use purposive sampling to ensure at least 60% patient sample is African American or Black or Hispanic/Latino/Latinx. Patient participants will be recruited to study using a combination of approaches including social media, referral and in-person outreach.

Quantitative and qualitative assessments will be used to collect information from providers and YMSM participants. Provider participants will complete Pre- and Post-training Provider Surveys, and patient interaction assessments (competency assessments) post-training and three months post-training. For Aim 2a, YMSM participants will be asked to complete a baseline assessment and quarterly assessments at 3, 6, 9, 12, 15, and 18 months to assess PrEP adherence; PrEP knowledge, usage and choice; sexual risk behaviors; HIV status of partners); and substance use assessment. A subset of YMSM participants from Aim 2a will be asked to complete an exit interview that will focus on understanding factors that influenced participants' selection of PrEP regimens, changes and/or discontinuations, as well as perceptions of the counseling they received by providers at PrEP initiation and follow-up, receipt of tools or materials that influenced choice and feasibility/acceptability of the EPICC+ app. We will also conduct focus groups with providers in Aim 2b to gather feedback on overall perceptions of the barriers and facilitators to EBT implementation within their clinical site. The study will also collect data from electronic health records; biological specimens collected at quarterly intervals; and a clinic assessment tool delivered every six months.

The total number of burden hours requested is 2,259 across 36 months of data collection. The total estimated annualized burden hours are 753. There are no costs to the participant other than their time.

Estimated Annualized Burden Hours

Type of respondent

Form name

Number of

respondents

Number of

responses

per

respondent

Average

burden

per response

(in hr)

Total burden

(in hr)

Health Practitioners

Aim 1 Provider Training Screener

20

1

5/60

2

Health Practitioners

Aim 1 Provider Training Contact Information

10

1

5/60

1

Health Practitioners

Aim 1 Provider Pre-Training Survey

10

1

15/60

3

Health Practitioners

Aim 1 Provider Post-Training Survey

10

1

15/60

3

Health Practitioners

Aim 1 Provider Patient Interaction Rating Scale (Baseline and Final)

10

2

15/60

5

General Public—Adults

Aim 2a Cohort Screener (English/Spanish)

267

1

5/60

22

General Public—Adults

Aim 2a Cohort Contact Information (English/Spanish)

134

1

5/60

11

General Public—Adults

Aim 2a Cohort HIPPA Form (English/Spanish)

134

1

5/60

11

General Public—Adults

Aim 2a Cohort Baseline Assessment (English/Spanish)

134

1

45/60

101

General Public—Adults

Aim 2a Cohort Follow-up Survey

(English/Spanish)

134

3

45/60

302

General Public—Adults

Aim 2a Cohort App Setup (English/Spanish)

134

1

30/60

67

General Public—Adults

Aim 2a Cohort Blood Collection Instructions (English/Spanish)

134

2

30/60

134

General Public—Adults

Aim 2a Cohort Exit Interview (English/Spanish)

15

1

60/60

15

Health Practitioners

Aim 2b Provider Focus Group Screener

32

1

5/60

3

Health Practitioners

Aim 2b Provider Focus Group Contact Information

16

1

5/60

1

Health Practitioners

Aim 2b Provider Pre-Focus Group Survey

16

1

5/60

1

Health Practitioners

Aim 2b Provider Focus Group Guide

16

1

2.0

32

Health Practitioners

Aims 1&2 Clinic Assessment (Baseline a& Final)

7

1

130/60

15

Health Practitioners

Aims 1&2 Clinic Assessment (every 6 months)

7

2

100/60

24

Total

753

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. 2026-13560 Filed 7-2-26; 8:45 am]

BILLING CODE 4163-18-P