View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-1100
ICR Reference No:
202112-0920-002
Status:
Historical Active
Previous ICR Reference No:
202103-0920-007
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:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/19/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/07/2021
Terms of Clearance:
Previous terms continue: 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. Limitations should also discuss any changes to the protocol.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2025
36 Months From Approved
01/31/2022
Responses
4,751
0
4,751
Time Burden (Hours)
1,594
0
1,594
Cost Burden (Dollars)
0
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:
86 FR 36555
07/12/2021
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 67952
11/30/2021
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
Phase 1 Consent
0920-1100, 0920-1100
Phase 1 Consent
,
Att 10b_Phase 1 Consent Form (Spanish)
Phase 1 Enrollment Survey
0920-1100, 0920-1100
Att 7a_Phase 1 Enrollment Survey (English)
,
Att 7b_Phase 1 Enrollment Survey (Spanish)
Phase 2 Behavioral Survey
0920-1100, 0920-1100
Att 8a_Phase 2 Behavioral Survey (English)
,
Att 8b_Phase 2 Behavioral Survey (Spanish)
Phase 2 Consent
0920-1100, 0920-1100
Att 11a_Phase 2 Consent form (English)
,
Att 8b_Phase 2 Behavioral Survey (Spanish)
Phase 2 HIV Symptom and Care Survey
0920-1100, 0920-1100
Att 9a_Phase 2 HIV Symptom and Care Survey (English)
,
Att 9b_Phase 2 HIV Symptom and Care Survey (Spanish)
ICR Summary of Burden
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)
1,594
1,594
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,258,676
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:
Odion Clunis 770 488-0045 lta2@cdc.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/07/2021
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