69638 Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Notices 

The Shigella Hypothesis Generating 

Questionnaire (SHGQ) will be 

administered by state and local public 

health officials via telephone interviews 

or self-administered web-based surveys 

with cases of shigellosis or their proxy 

who are part of a shigellosis cluster or 

outbreak. The SHGQ will collect 

information on demographics 

characteristics, household information 

and family member event and activity 

attendance, clinical signs and 

symptoms, medical care and treatment 

information, travel history, contact with 

international travelers or other ill 

individuals, event and activity 

attendance, limited food and water 

exposure, work, visit, and volunteer 

locations, childcare and school 

attendance, and recent sexual partner(s) 

and activity. This interview/survey 

activity is consistent with the state’s 

existing authority to investigate reports 

of notifiable diseases for routine 

surveillance purposes; therefore, formal 

consent to participate in the activity is 

not required. However, cases may 

choose not to participate and may 

choose not to answer any question they 

do not wish to answer. It will take 

health department personnel 

approximately 45 minutes to administer 

the questionnaire to an estimated 1,500 

patient respondents. This results in an 

estimated annual burden to the public 

of 1,125 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Shigellosis case patients identified as part of 

outbreak or cluster investigations.

Shigella Hypothesis Generating Questionnaire.1500 1 45/60 

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. 2023–22273 Filed 10–5–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–24–23AQ] 

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 ‘‘Understanding 

HIV/STD Risk and Enhancing PrEP 

Implementation Messaging in a Diverse 

Community-Based Sample of Gay, 

Bisexual, and Other Men Who Have Sex 

with Men in a Transformational Era 

(MIC–DROP)’’ 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 November 

16, 2022, to obtain comments from the 

public and affected agencies. CDC 

received two 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 

‘‘Understanding HIV/STD Risk and 

Enhancing PrEP Implementation 

Messaging in a Diverse CommunityBased Sample of Gay, Bisexual, and 

Other Men Who Have Sex with Men in 

a Transformational Era (MIC–DROP)’’— 

New—National Center for HIV, Viral 

Hepatitis, STD, TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

CDC is requesting approval for three 

years for a data collection titled 

‘‘Understanding HIV/STD Risk and 

Enhancing PrEP Implementation 

Messaging in a Diverse CommunityBased Sample of Gay, Bisexual, and 

Other Men Who Have Sex with Men in 

a Transformational Era (MIC–DROP).’’ 

The purpose of the information 

collection is to understand men’s 

strategies to prevent HIV and sexually 

transmitted infections (STIs), including 

preexposure prophylaxis (PrEP) use and 

adherence, condom use, sexual risktaking behavior, and substance-using 

behaviors. This study will assess men’s 

use and preferences for prevention 

modalities and their awareness, 

knowledge, beliefs, and perceptions 

about products that prevent the 

transmission of HIV and other sexually 

transmitted diseases (STD). This study 

will also conduct structured 

assessments to identify HIV prevention 

gaps and test prevention messages for 

men who have sex with men (MSM). 

The information collected in this 

study will be used to: (1) describe realworld HIV and STI prevention strategies 

including PrEP and condom use and 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Notices 69639 

adherence; (2) better understand men’s 

use, preferences, knowledge, and 

perceptions about prevention 

modalities; (3) develop rapid reports 

that will allow for summary 

recommendations concerning gaps in 

prevention protection and message 

testing; and (4) provide timely new 

information to public health programs 

and decision makers. The study will be 

carried out in three cities: Atlanta, GA; 

Chicago, IL; and San Diego, CA. 

Participants will include 1,275 HIVnegative men ages 18 and older. Cohort 

participants will identify as cisgender 

male; report sex with a man in the last 

six months; and be fluent in written/ 

spoken English or Spanish. We will use 

purposive sampling to ensure that 60% 

of participants will be PrEP users at 

baseline, and 40% will not be using 

PrEP at that point. We will also 

oversample Black/African American 

and Hispanic/Latino MSM to ensure 

that a minimum of 30% each are 

represented in the cohort sample. 

Participants will be recruited using a 

combination of approaches including 

social media, referral, and in-person 

outreach. 

A computer-assisted quantitative 

assessment will collect information 

about participants’ use of prevention 

modalities, as well as their awareness, 

knowledge, beliefs, and perceptions 

about HIV/STI prevention products and 

prevention messages. The study will 

utilize the SMaRT (Study Management 

and Retention Toolkit) system, a study 

management platform for participant 

management that includes a HIPPAcompliant companion mobile app that 

study participants install on their smart 

phones. The app supports several key 

functions of study participation 

including notifications of surveys 

available, administration of surveys, a 

messaging center, appointment 

scheduling, secure HIPPA-compliant 

document upload and return of 

laboratory results, and a HIPPAcompliant telehealth video conference 

platform. At six-month intervals starting 

at baseline, all participants will be 

mailed self-collection kits to provide 

samples for HIV and STI testing. 

Specimens for STI testing include urine, 

rectal, and pharyngeal swabs for 

gonorrhea and chlamydia and dried 

blood spot (DBS) for syphilis testing. 

HIV kits will collect DBS for 4th 

generation HIV testing. Tests will be 

shipped from, returned to, and 

processed by a CLIA-certified 

laboratory. Participants will also have 

the option to self-collect their 

specimens at a study site, where study 

staff will provide them with a selfcollection kit and a private room in 

which to collect their specimens. A 

subset of the participant cohort will be 

invited to further participate in 

qualitative data collection activities 

including focus groups and in-depth 

interviews. The focus groups will assess 

the participants’ awareness of PrEP 

messages, preferences for PrEP 

messages, and perceived impact/efficacy 

of HIV prevention and PrEP messages. 

The in-depth interviews will assess 

men’s PrEP experiences, their 

preferences for PrEP and other HIV 

prevention products, and further 

explore their reactions to prevention 

messages. Participants will have the 

option to join virtual or in-person focus 

groups and interview sessions. 

Total study enrollment is 1,275 over 

the three-year data collection period. 

Based on screening and enrollment 

numbers from similar studies, we 

estimate we will need to screen 2,550 

individuals (850 annually) to reach total 

enrollment. The screening process will 

take approximately five minutes to 

complete. Participants will be 

rescreened at the time of the enrollment 

visit. Contact information will be 

collected from 1,275 participants (425 

annually) and will take approximately 

five minutes to complete. The 

quantitative assessment will take 45 

minutes to complete and will be 

delivered to 1,275 participants (850 

annually) a total 8 times. The SMaRT 

app install will take 10 minutes to 

complete and will be completed by 

1,275 participants (425 annually). The 

specimen kit for HIV testing will take 

approximately 20 minutes to complete 

and will be distributed to 1,275 

participants (850 annually) a total of 

four times. The specimen kit for STI 

testing will take approximately 30 

minutes to complete and will be 

distributed to 1,275 participants (850 

annually) a total of four times. A subset 

of the cohort participants will be invited 

to participate in qualitative data 

collection activities. A total of 144 

participants (48 annually) will engage in 

a focus group that is estimated to take 

90 minutes to complete, and 45 

participants will be invited to 

participate in a series of three in-depth 

interviews to be administered at sixmonth intervals. The interviews will 

take approximately 60 minutes to 

complete. 

CDC is requesting 12,996 total burden 

hours across 3 years of data collection. 

The total estimated annualized burden 

hours are 4,332. Total burden for each 

activity has been rounded to the nearest 

whole hour. Participation of 

respondents is voluntary. There is no 

cost to participants 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) 

General Public—Adults ................................... Eligibility Screener .......................................... 850 2 5/60 

General Public—Adults ................................... Locator Form .................................................. 425 1 5/60 

General Public—Adults ................................... Quarterly Assessment .................................... 850 4 45/60 

General Public—Adults ................................... SMaRT App Installation ................................. 425 1 10/60 

General Public—Adults ................................... Sample Collection for HIV Test ..................... 850 2 20/60 

General Public—Adults ................................... Sample Collection for STI Test ...................... 850 2 30/60 

General Public—Adults ................................... Focus Group .................................................. 48 1 90/60

General Public—Adults ................................... In-Depth interview .......................................... 45 1 60/60 


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69640 Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Notices 

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. 2023–22271 Filed 10–5–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-24–1402; Docket No. CDC–2023– 

0081] 

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 or continuing information 

collection, as required by the Paperwork 

Reduction Act of 1995. This notice 

invites comments on a proposed 

information collection titled 

Surveillance of HIV-related service 

barriers among Individuals with Early or 

Late HIV Diagnoses (SHIELD), which 

collects information from people who 

were recently diagnosed with HIV at 

early (Stage 0) or late diagnosis (Stage 3) 

to understand barriers to HIV 

prevention and testing services to 

contributing to transmission. 

DATES: CDC must receive written 

comments on or before December 5, 

2023. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0081 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 the 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 using 

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 

Surveillance of HIV-related service 

barriers among Individuals with Early or 

Late HIV Diagnoses (SHIELD) (OMB 

Control No. 0920–1402, Exp. 5/31/ 

2026)—Revision—National Center for 

HIV, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

National HIV Surveillance System 

(NHSS) data indicate that 37,968 

adolescents and adults received an HIV 

diagnosis in the United States and 

dependent areas in 2018. During 2015– 

2019, the overall rate of annual 

diagnoses decreased only slightly, from 

12.4 to 11.1 per 100,000. Although not 

every jurisdiction reports complete 

laboratory data needed to identify stage 

of infection, data from most 

jurisdictions show that many of these 

cases were classified as Stage 0 (7.9%) 

or Stage 3 (20.2%) infection (i.e., cases 

diagnosed in early infection or late 

infection, respectively). Early and late 

diagnoses represent recent failures in 

prevention and testing systems, 

respectively, and opportunities to 

understand needed improvements in 

these systems. 

The NHSS classifies HIV infections as 

Stage 0 if the first positive HIV test was 

within six months of a negative HIV 

test. Persons who received a diagnosis at 

Stage 0 (i.e., early diagnosis) were able 

to access HIV testing shortly after 

infection yet were unable to benefit 

from biomedical and behavioral 

interventions to prevent HIV infection. 

The federal Ending the HIV Epidemic in 

the U.S. (EHE) initiative prioritizes the 

provision of HIV preexposure 

prophylaxis (PrEP), syringe services 

programs, treatment as prevention 

efforts, and other proven 

interventions—as part of the Prevent 

pillar of the EHE initiative—to prevent 

new HIV infections. 

HIV infections are classified as Stage 

3 (AIDS) by the presence of an AIDSdefining opportunistic infection or by 

the lowest CD4 lymphocyte test result. 

Persons with Stage 3 infection at the 

time of their initial HIV diagnosis (i.e., 

late diagnosis) did not benefit from 

timely receipt of testing or HIV 

prevention interventions and were 

likely unaware of their infection for a 

substantial time. Nationally, an 

estimated 13.3% of persons with HIV 

are unaware of their infection, 

contributing to an estimated 40% of all 

ongoing transmission. Increasing early 

diagnosis is a crucial pillar of efforts to 

end HIV in the United States. Given the 

continued occurrence of HIV infections 

in the United States, the barriers and 

gaps associated with low uptake of HIV 

testing and prevention services must be 

addressed to reduce new infections and 

facilitate timely diagnosis and 

treatment. Therefore, CDC is sponsoring 

this data collection to improve 

understanding of barriers and gaps 

associated with new infection and late 

diagnosis in the era of multiple testing 


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