Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 36555 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–21–1100; Docket No. CDC–2021– 

0066] 

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 and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Identification of Behavioral and 

Clinical Predictors of Early HIV 

Infection (Project DETECT), which 

collects information from people testing 

for HIV in order to compare the 

performance characteristics of new 

point of care HIV tests for detection of 

early HIV infection and to identify 

behavioral and clinical predictors of 

early HIV infection. 

DATES: CDC must receive written 

comments on or before September 10, 

2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0066 by any of the following methods: 

• Federal eRulemaking Portal: 

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–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(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– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7570; 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 

Identification of Behavioral and 

Clinical Predictors of Early HIV 

Infection (Project DETECT)—(OMB 

Control No. 0920–1100, Exp. 1/31/ 

2022)—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 Centers for Disease Control and 

Prevention (CDC), National Center for 

HIV/AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Division of 

HIV/AIDS Prevention (DHAP) requests a 

three-year Extension for a data 

collection titled Identification of 

Behavioral and Clinical Predictors of 

Early HIV Infection (Project DETECT). 

CDC provides guidelines for HIV 

testing and diagnosis for the United 

States, as well as technical guidance for 

its grantees. The purpose of this project 

is to assess characteristics of HIV testing 

technologies to update these guidance 

documents to reflect the latest available 

testing technologies, their performance 

characteristics, and considerations 

regarding their use. Specifically, CDC 

will describe behavioral and clinical 

characteristics of persons with early 

infection to help HIV test providers 

(including CDC grantees) choose which 

HIV tests to use, and target tests 

appropriately to persons at different 

levels of risk. This information will be 

disseminated primarily through 

guidance documents and articles in 

peer-reviewed journals. 

The primary study population will be 

persons at high risk for, or diagnosed 

with HIV infection, many of whom will 

be men who have sex with men (MSM), 

transgender women, minorities, and 

persons who inject drugs (PWIDs) 

because the majority of new HIV 

infections occur each year among these 

populations. The goals of the project are 

to: (1) Characterize the performance of 

new HIV tests for detecting established 

and early HIV infection at the point of 

care, relative to each other and to 

currently used gold standard, non-pointof-care (POC) tests, and (2) identify 

behavioral and clinical predictors of 

early HIV infection. 

Project DETECT will enroll 1,867 

persons annually from two study sites 

(Seattle and Baltimore). The study will 

be conducted in two phases. 

Phase 1: After a client consents to 

participate, he/she will be assigned a 

unique Participant ID, and will then 

undergo testing with up to seven new 

HIV tests under study. While awaiting 

test results, participants will undergo 

additional specimen collections and 

complete the Phase 1 Enrollment 

Survey. 

Phase 2: All Phase 1 participants 

whose results on the seven tests under 

investigation are not in agreement with 

one another test (discordant), will be 

considered to have a potential early HIV 

infection. Nucleic amplification testing 

that detects viral nucleic acids will be 

conducted to confirm an HIV diagnosis 

and rule out false positives. Study 

investigators expect that each year, 50 

participants with discordant test results 

will be invited to participate in serial 

follow-up specimen collections to assess 

the time point at which all HIV test 

results resolve and become concordant 

positive (indicating enrollment during 

early infection) or concordant negative 


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36556 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 

(indicating one or more false-positive 

test results in Phase 1). 

The follow-up schedule will consist 

of up to nine visits scheduled at regular 

intervals over a 70-day period. At each 

follow-up visit, participants will be 

tested with the new HIV tests and 

additional oral fluid and blood 

specimens will also be collected for 

storage and use in future HIV test 

evaluations at CDC. Participants will be 

followed only to the point at which all 

their test results become concordant. At 

each time point, participants will be 

asked to complete the Phase 2 HIV 

Symptom and Care survey to collect 

information on symptoms associated 

with early HIV infection as well as 

access to HIV care and treatment since 

the last Phase 2 visit. When all tests 

become concordant (i.e., at the last 

Phase 2 visit) participants will complete 

the Phase 2 Behavioral Survey to 

identify any behavioral changes during 

follow-up. Of the 50 Phase 2 

participants; it is estimated that no more 

than 26, annually, will have early HIV 

infection. 

All data for the proposed information 

collection will be collected via an 

electronic Computer Assisted SelfInterview (CASI) survey. Participants 

will complete the surveys on an 

encrypted computer, with the exception 

of the Phase 2 Symptom and Care 

survey, which will be administered by 

a research assistant and then 

electronically entered into the CASI 

system. Data to be collected via CASI 

include questions on sociodemographic 

characteristics, medical care, HIV 

testing, pre-exposure prophylaxis, 

antiretroviral treatment, sexually 

transmitted diseases (STD) history, 

symptoms of early HIV infection, 

substance use and sexual behavior. 

Data from the surveys will be merged 

with HIV test results and relevant 

clinical data using the unique 

identification (ID) number. Data will be 

stored on a secure server managed by 

the awardee’s Information Technology 

(IT) Services. The participation of 

respondents is voluntary. There is no 

cost to the respondents other than their 

time. The total estimated annual burden 

hours for the proposed project are 1,594 

hours. 

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) 

Persons eligible for 

study.

Phase 1 Consent ................................................. 2,334 1 15/60 584 

Enrolled participants ...... Phase 1 Enrollment Survey ................................. 1,867 1 30/60 934 

Phase 2 Consent ................................................. 50 1 15/60 13 

Phase 2 HIV Symptom and Care survey ............ 50 9 5/60 38 

Phase 2 Behavioral Survey ................................. 50 1 30/60 25 

Total ........................ .............................................................................. ........................ ........................ ........................ 1,594 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–14754 Filed 7–9–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–21–1242] 

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 Strengthening 

U.S. Response to Resistant Gonorrhea 

(SURRG) 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 

September 30, 2020 to obtain comments 

from the public and affected agencies. 

CDC received one non-substantive 

comment 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 

Strengthening U.S. Response to 

Resistant Gonorrhea (SURRG) (OMB 

Control No. 0920–1242, Exp. 9/30/ 

2021)—Revision—National Center for 

HIV/AIDS, Viral Hepatitis, STD, and TB 


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