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:
0920-1428
ICR Reference No:
202410-0920-016
Status:
Historical Active
Previous ICR Reference No:
202402-0920-005
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1428-25AJ
Title:
[NCHHSTP] mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
Yes
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/20/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/19/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2027
01/31/2027
01/31/2027
Responses
1,135
0
1,135
Time Burden (Hours)
549
0
549
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of the mChoice project is to rigorously evaluate the use of provider and patient education and support tools in clinical settings to increase PrEP screening, counseling, initiation, adherence, and persistence by MSM. This research project will involve interaction with human participants and intends to collect new individually identifiable data and biospecimens from the participants. This project is considered human subjects research and will be covered by the Paperwork Reduction Act. The mChoice intervention will target healthcare providers and PrEP users. The study will provide training to healthcare providers to improve knowledge of PrEP clinical guidelines and enhance provider communications with their patients. PrEP users will receive CleverCap, an electronic medication monitoring device that is linked to the CleverCap mobile phone application that provides medication dispensing information and reminders to support medication adherence, as well as health information and appointment reminders. This non-substantive change request involves minor edits to instruments and a consent form. The burden remains the same.
Authorizing Statute(s):
None
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:
88 FR 56834
08/21/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 78043
11/14/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
13
IC Title
Form No.
Form Name
CleverCap App Setup
n/a, n/a
Att 4e_CleverCap App Setup English
,
Att 4e_CleverCap App Setup Spanish
Clinic Assessment Every Six Months
0920-22FZ
Att 4m_Clinic Assessment Every 6 Months
Clinical Assesment Baseline & Final
0920-22FZ
Att 4l_Clinic Assessment Baseline and Final
Patient Baseline
n/a, n/a
Att 4c_Patient Baseline Assessment English.docx
,
Att 4c_Patient Baseline Assessment Spanish
Patient Interview Guide
0920-22FZ, 0920-22FZ
Att 4f_Patient Interiew Guide English.docx
,
Att 4f_Patient Interiew Guide Spanish
Patient Locator Form
0920-22FZ, 0920-22FZ
Patient Locator Form _English
,
Att 4b_Patient Locator Form Spanish
Patient Quarterly Assessment
n/a, n/a
Att 4d_Patient Quarterly Assessment English
,
Att 4d_Patient Quarterly Assessment Spanish
Patient Screener (English/Spanish)
0920-25AJ, 0920-25AJ
Patient Screener (English)
,
Patient Screener (Spanish)
Provider Interview
0920-22FZ
Att 4k_Provider Interview Guide
Provider Locator Form
0920-22FZ
Att 4h_Provider Locator Form
Provider Post-Training Assessment
0920-22FZ
Att 4j_Provider Post-Training Assessment
Provider Pre-Training Assessment
n/a
Att 4i_Provider Pre-Training Assessment
Provider Screening
0920-22FZ
Att 4g_Provider Screener
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
1,135
1,135
0
0
0
0
Annual Time Burden (Hours)
549
549
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:
$1,112,799
Does this IC contain surveys, censuses, or employ statistical methods?
No
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:
Yes
Description/Changes for Common Form Usage:
This request includes changes to the inclusion criteria and sexual behavior screening questions. In addition, CDC is also revising the SSA and SSB to reflect changes in CDC staffing on the project. We are also updating the race and ethnicity questions to reflect the new standards announced by the Management and Budget Office on 03/29/2024 (Revisions to OMB's Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, 89 FR 22182).
Approved RCFs using this ICR
Agency/Sub Agency
RCF ID
RCF Title
RCF Status
IC Title
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:
11/19/2024
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