Information Collection Request

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

ICR 201811-0920-002 · OMB 0920-1100 · Active

Forms and Documents
DocumentTypeStatusAvailability
Phase 2 Behavioral Survey Form and Instruction Modified Available
Phase 2 HIV Symptom and Care Survey Form and Instruction Modified Available
Phase 1 Enrollment Survey B Form and Instruction Modified Available
Phase 1 Enrollment Survey A Form and Instruction Modified Repair queued
Att 15_PIA.pdf Supplementary Document Uploaded 2018-11-16 Available
Att 14_Project Determination.pdf Supplementary Document Uploaded 2018-11-16 Available
Att 13_Supplemental Study Information.docx Supplementary Document Uploaded 2018-11-16 Available
Att 5_IRB Approval.pdf Supplementary Document Uploaded 2018-11-16 Available
Att 4_Certificate of Confidentiality.pdf Supplementary Document Uploaded 2018-11-16 Available
Att 3_References.docx Supplementary Document Uploaded 2018-11-16 Available
Att 2_60-Day FRN Published.pdf Supplementary Document Uploaded 2018-11-16 Available
Att 1_Auth Legislation.docx Supplementary Document Uploaded 2018-11-16 Available
Supporting Statement B_11082018.docx Supporting Statement B Uploaded 2018-11-16 Available
Supporting Statement A_11082018.docx Supporting Statement A Uploaded 2018-11-16 Available
IC Document Collections
IC IDCollectionTypeStatusForm
218949 Att 10_Phase 2 Consent Other-Consent Form (English) Modified
218948 Phase 1 Consent Other-Consent Form (English) Modified
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 Modified
ICR Details
0920-1100 201811-0920-002
Active 201511-0920-006
HHS/CDC 15AEZ
Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)
Extension without change of a currently approved collection   No
Regular
Approved without change 01/16/2019
Retrieve Notice of Action (NOA) 12/11/2018
Approved consistent with the understanding that any forthcoming publications or communications of the study outcomes will clearly convey the potential limitations in the generalizability of the behavioral findings to other subpopulations and other geographic areas.
  Inventory as of this Action Requested Previously Approved
01/31/2022 36 Months From Approved 02/28/2019
4,751 0 4,751
2,110 0 2,110
0 0 0

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.

US Code: 42 USC 241 Name of Law: Public Health Services Act
  
None

Not associated with rulemaking

  83 FR 42301 08/21/2018
83 FR 63512 12/10/2018
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 4,751 4,751 0 0 0 0
Annual Time Burden (Hours) 2,110 2,110 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$867,704
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Renita Macaluso 770 488-6458 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
12/11/2018