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)

ICR 202103-0920-010

OMB: 0920-1357

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
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Form and Instruction
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Form and Instruction
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Supporting Statement B
2021-06-17
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supporting Statement A
2021-06-16
ICR Details
202103-0920-010
Received in OIRA
HHS/CDC 0920-21AC
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)
New collection (Request for a new OMB Control Number)   No
Regular 06/24/2021
  Requested Previously Approved
36 Months From Approved
4,898 0
1,067 0
20,848 0

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.

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  85 FR 83087 12/21/2020
86 FR 33294 06/24/2021
Yes

  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 4,898 0 0 4,898 0 0
Annual Time Burden (Hours) 1,067 0 0 1,067 0 0
Annual Cost Burden (Dollars) 20,848 0 0 20,848 0 0
Yes
Miscellaneous Actions
No
This is a new, one-time information collection.

$1,346,479
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Renita Macaluso 770 488-6458 [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.
06/24/2021


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