Information Collection Request

Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)

ICR 202103-0920-007 · OMB 0920-1100 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0920-1100 can be found here:

2021-12-07 - Extension without change of a currently approved collection

Forms and Documents

Document	Type	Status	Availability
Phase 2 Behavioral Survey	Form and Instruction	Modified	Repair queued
Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified	Available
Phase 1 Enrollment Survey B	Form and Instruction	Modified	Repair queued
Phase 1 Enrollment Survey A	Form and Instruction	Removed	Repair queued
Summary of changes to questionnaire - DETECT 2.0 - 03.11.2021.xlsx	Supplementary Document	Uploaded 2021-03-25	Missing upstream
Justification for Change for 0920-1100_DETECT clean_final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-03-25	Missing upstream
Att 15_PIA.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 14_Project Determination.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 13_Supplemental Study Information.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 5_IRB Approval.pdf	Supplementary Document	Uploaded 2018-11-16	Missing upstream
Att 4_Certificate of Confidentiality.pdf	Supplementary Document	Uploaded 2018-11-16	Missing upstream
Att 3_References.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 2_60-Day FRN Published.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Supporting Statement B_11082018.docx	Supporting Statement B	Uploaded 2018-11-16	Repair queued
2021 03 04 Supporting Statement A_061318_rev15Mar21_clean.docx	Supporting Statement A	Uploaded 2021-03-25	Repair queued

IC Document Collections

IC ID	Collection	Type	Status
218949	Att 10_Phase 2 Consent	Other-Consent Form (English)	Unchanged
218948	Phase 1 Consent	Other-Consent Form (English)	Unchanged
218947	Phase 2 Behavioral Survey	Form and Instruction	Modified
218946	Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified
218945	Phase 1 Enrollment Survey B	Form and Instruction	Modified
218918	Phase 1 Enrollment Survey A	Form and Instruction	Removed

ICR Details

OMB Control No: 0920-1100	ICR Reference No: 202103-0920-007
Status: Received in OIRA	Previous ICR Reference No: 201811-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1100-21DY
Title: Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 03/26/2021

	Requested	Previously Approved
Expiration Date	01/31/2022	01/31/2022
Responses	4,751	4,751
Time Burden (Hours)	1,594	2,110
Cost Burden (Dollars)	0	0

Abstract: CDC provides guidelines for HIV testing and diagnosis for the United States, as well as technical guidance for its grantees. The goals of the project are to: 1) characterize the performance of new HIV tests for detecting established and acute HIV infection at the point of care (POC) relative to each other and currently used gold standard, non-POC tests, and 2) identify behavioral and clinical predictors of early HIV infection. CDC will use the HIV testing data collected in this project to update HIV testing guidance documents to reflect the latest available testing technologies and their performance characteristics. CDC will use the information on behavioral and clinical characteristics of persons with early infection to help HIV test providers (including CDC grantees) more effectively target the tests designed to detect early HIV infection, which are the most expensive HIV tests and are most appropriately used to test those at highest risk of infection. The main purpose of this Change Request is to allow collection continuation with an additional site with other minor changes.

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Services Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 42301	08/21/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 63512	12/10/2018
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Att 10_Phase 2 Consent
Phase 1 Consent
Phase 1 Enrollment Survey A	n/a, n/a, n/a	Phase 1 Enrollment Survey A (English) , Phase 1 Enrollment Survey A (Spanish) , Phase 1 Enrollment Survey A (screen shots)
Phase 1 Enrollment Survey B	n/a, n/a, n/a, n/a	Phase 1 Enrollment Survey B (English) , Phase 1 Enrollment Survey B (Spanish) , Phase 1 Enrollment Survey B (screen shots) , Phase 1 Enrollment Survey B (screen shots in Spanish)
Phase 2 Behavioral Survey	n/a, n/a, n/a, n/a	Phase 2 Behavioral Survey (English) , Phase 2 Behavioral Survey (Spanish) , Phase 2 Behavioral Survey (screen shots in Spanish) , Phase 2 Behavioral Survey (screen shots in English)
Phase 2 HIV Symptom and Care Survey	n/a, n/a, n/a, n/a	Phase 2 HIV Symptom and Care Survey (English) , Phase 2 HIV Symptom and Care Survey (Spanish) , Phase 2 HIV Symptom and Care Survey (screen shots) , Phase 2 HIV Symptom and Care Survey (screen shots in Spanish)

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	4,751	4,751	1,667	-1,667
Annual Time Burden (Hours)	1,594	2,110	734	-1,250
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: One instrument was eliminated and the burden time was reduced on one survey.

Annual Cost to Federal Government: $867,704

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Kevin Joyce 404 639-1944 [email protected]

Common Form ICR: No