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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202112-0920-002 · OMB 0920-1100 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1100 Phase 2 Consent Form Modified Missing upstream
Form 0920-1100 Phase 1 Consent Form Modified Available
Form 0920-1100 Phase 2 Behavioral Survey Form and Instruction Modified Repair queued
Form 0920-1100 Phase 2 HIV Symptom and Care Survey Form and Instruction Modified Available
Form 0920-1100 Phase 1 Enrollment Survey Form and Instruction Modified Repair queued
Att 13 Project Determination.pdf Supplementary Document Uploaded 2021-12-07 Repair queued
Privacy Act Checklist.docx Supplementary Document Uploaded 2021-12-07 Repair queued
Att 4 IRB approval (JHU_Hamill).pdf Supplementary Document Uploaded 2021-12-07 Repair queued
Att 3_References.docx Supplementary Document Uploaded 2021-12-07 Repair queued
Att 1_Auth Legislation.docx Supplementary Document Uploaded 2021-12-07 Missing upstream
Summary of changes to questionnaire - DETECT 2.0 - 03.11.2021.xlsx Supplementary Document Uploaded 2021-03-25 Repair queued
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 Repair queued
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 Missing upstream
Supporting Statement B.docx Supporting Statement B Uploaded 2021-12-07 Repair queued
Supporting Statement A.docx Supporting Statement A Uploaded 2021-12-07 Available
IC Document Collections
IC IDCollectionTypeStatusForm
218949 Phase 2 Consent Form Modified
218948 Phase 1 Consent Form 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 Form and Instruction Modified
ICR Details
0920-1100 202112-0920-002
Received in OIRA 202103-0920-007
HHS/CDC 0920-1100-21DY
Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)
Extension without change of a currently approved collection   No
Regular 12/07/2021
  Requested Previously Approved
36 Months From Approved 01/31/2022
4,751 4,751
1,594 1,594
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. The main purpose of this Change Request is to allow collection continuation with an additional site with other minor changes.
US Code: 42 USC 241 Name of Law: Public Health Services Act
  
None
Not associated with rulemaking
  86 FR 36555 07/12/2021
86 FR 67952 11/30/2021
No
  Total Request 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) 1,594 1,594 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,258,676
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Odion Clunis 770 488-0045 [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.
12/07/2021