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:
202311-0920-002
Status:
Historical Active
Previous ICR Reference No:
202209-0920-005
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1357-24AQ
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:
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:
11/03/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/02/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2024
12/31/2024
12/31/2024
Responses
3,516
0
4,898
Time Burden (Hours)
809
0
1,067
Cost Burden (Dollars)
6,037
0
20,848
Abstract:
CDC is re-prioritizing the aims/components of the project and adjusting the enrollment totals for the different aims accordingly. This change is made in response to changing priorities in the field of point-of-care nucleic acid (POC NAT) testing for HIV, and in light of study progress and the remaining study timeline.
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
HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey
0920-1357, 0920-1357
Study Visit Survey
,
GAIN Study Visit Survey - Revised 09SEP2022
Acceptability/Feasibility Assessment Among Clinical and Community Providers
0920-1357
Participant Focus Group/Interview Guide Gay City and Madison Clinic Testing, PEP & PrEP (participants testing negative only)
Baseline Data Collection
HIV-negative Patients Seeking HIV Testing - ROI Form
0920-1357
Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
HIV-negative Patients Seeking HIV Testing - Study Visit Survey
0920-1357, 0920-1357
Study Visit Survey (SCREENSHOTS)
,
GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form
0920-1357
Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
Monthly Study Report Form
n/a
Monthly Study Report Form
POC NAT Acceptability Survey
0920-1357
NAT Acceptability Survey (SCREENSHOTS)
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
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)
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
3,516
4,898
0
-1,382
0
0
Annual Time Burden (Hours)
809
1,067
0
-258
0
0
Annual Cost Burden (Dollars)
6,037
20,848
0
-14,811
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
CDC is re-prioritizing the aims/components of the project and adjusting the enrollment totals for the different aims accordingly. This change is made in response to changing priorities in the field of point-of-care nucleic acid (POC NAT) testing for HIV, and in light of study progress and the remaining study timeline.
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:
Thelma Sims 4046394771
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:
11/02/2023
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