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:
0920-1357
ICR Reference No:
202209-0920-005
Status:
Historical Active
Previous ICR Reference No:
202103-0920-010
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1357-22IR
Title:
The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
04/13/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/13/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2024
12/31/2024
12/31/2024
Responses
4,898
0
4,898
Time Burden (Hours)
1,067
0
1,067
Cost Burden (Dollars)
20,848
0
20,848
Abstract:
GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. These data will describe the real-world performance and clinical effects of HIV RNA POC NAT testing. CDC will not receive any personally-identifiable information. This Non-Substantive Change Request is submitted to modify the incentives provided to study groups and to improve study implementation logistics. The original plan offered varying incentives by study group which presents operational challenges. The change provides a consistent incentive plan across the primary study groups and also modifies language in consent forms. There is no change to the approved burden hours.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: Public Health Service 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:
85 FR 83087
12/21/2020
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 33294
06/24/2021
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
12
IC Title
Form No.
Form Name
Acceptability/Feasibility Assessment Among Clinical and Community Providers
n/a
Participant Focus Group / Interview Guide
Baseline Data Collection
Monthly Study Report Form
n/a
Monthly Study Report Form
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form
n/a
Release of Information Form
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey
0920-1357, n/a
Study Visit Survey
,
GAIN Study Visit Survey - Revised 09SEP2022
Participants in POC NAT Acceptability Survey
n/a
NAT Acceptability Survey
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form
n/a
Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey
0920-1357, n/a
Study Visit Survey
,
GAIN Study Visit Survey - Revised 09SEP2022
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form
n/a
Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey
0920-1357, n/a
Study Visit Survey
,
GAIN Study Visit Survey - Revised 09SEP2022
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form
n/a
Release of Information Form
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form
0920-1357, n/a
Study Visit Survey
,
GAIN Study Visit Survey - Revised 09SEP2022
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
4,898
4,898
0
0
0
0
Annual Time Burden (Hours)
1,067
1,067
0
0
0
0
Annual Cost Burden (Dollars)
20,848
20,848
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:
$1,346,479
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:
Jeffrey Zirger 404 639-7118 wtj5@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:
09/13/2022
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