View Information Collection Request (ICR) Package
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View ICR - Agency Submission
COMMENT
Time Remaining
Days
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OMB Control No:
0920-1357
ICR Reference No:
202512-0920-007
Status:
Received in OIRA
Previous ICR Reference No:
202411-0920-009
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-25-0177
Title:
[NCHHSTP] 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:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
01/13/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
423
0
Time Burden (Hours)
49
0
Cost Burden (Dollars)
0
0
Abstract:
The purpose of this information collection is to determine the acceptability and feasibility of NATs that are used at the point-of-care (POC NAT) implementation in clinical and community settings. POC NATs have the potential to help address some of the remaining challenges to ending the HIV epidemic in the United States by assisting with early detection of acute HIV infection and by providing a more efficient viral load monitoring tool for people living with HIV. This study is the first of its kind in the US and is critical to understanding the utility of rapid point-of-care (POC) nucleic acid tests (NAT) and provider and patient perspectives on its use in the US.
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:
90 FR 1501
01/08/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 59831
12/22/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Acceptability Survey
0920-25-0177
Acceptability Survey
Follow Up Phone Call Survey
0920-25-0177
Follow Up Phone Call Survey
Gay City Data Collection
0920-25-0177
Gay City Data Collection
HIV-negative Patients Seeking HIV Testing - Study Visit Survey
0920-1357, 0920-1357
Study Visit Survey (SCREENSHOTS)
,
GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
Madison Clinic Data Collection
0920-25-0177
Madison Clinic Data Collection
Participant Focus Group and Interview Guide
0920-25-0177
Participant Focus Group and Interview Guide
Provider Interview Guide
0920-25-0177
Provider Interview Guide
RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form
0920-1357
Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form
0920-1357, 0920-1357
Study Visit Survey (SCREENSHOTS)
,
GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
Release of Information
0920-25-0177
Release of Information
Screen and Link
0920-25-0177
Screen and Link
Study Visit Survey
0920-25-0177
Study Visit Survey
ICR Summary of Burden
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
423
0
0
423
-474
474
Annual Time Burden (Hours)
49
0
0
49
-101
101
Annual Cost Burden (Dollars)
0
0
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:
This is a reinstatment of a collection that expried on 12/21/2024 seeking three years of approval.
Annual Cost to Federal Government:
$346,459
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:
01/13/2026
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