[NCHHSTP] Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-24DF In-Depth Interview Consent Spanish	Form	Modified	Available
Form 0920-24DF In-Depth Interview Consent English	Form	Modified	Available
Form 0920-24DF In-Depth Interview	Form	Modified	Repair queued
Form 0920-24DF Att 5b_Focus Group Consent Spanish_clean	Form	Modified	Available
Form 0920-24DF Focus Group Consent English	Form	Modified	Available
Form 0920-24DF Focus Group Guide	Form	Modified	Repair queued
STI Sample Collection (Spanish)	Form and Instruction	Unchanged	Available
STI Sample Collection	Form and Instruction	Unchanged	Available
STI Sample Collection	Form and Instruction	Unchanged	Repair queued
HIV Sample Collection (Spanish)	Form and Instruction	Unchanged	Available
HIV Sample Collection	Form and Instruction	Unchanged	Available
HIV sample collection	Form and Instruction	Unchanged	Repair queued
SMART App Installation (Spanish)	Form and Instruction	Unchanged	Available
SMART App Installation	Form and Instruction	Unchanged	Available
SMaRT App Install	Form and Instruction	Unchanged	Repair queued
Form 0920-24DF Quarterly assessment Spanish	Form	Modified	Available
Form 0920-24DF Quarterly assessment English	Form	Modified	Available
Form 0920-24DF Quarterly Assessment	Form	Modified	Repair queued
Form 0920-24DF Registration Contact Information Form Spanish	Form	Modified	Available
Form 0920-24DF Registration Contact Information Form English	Form	Modified	Available
Form 0920-24DF Registration Contact Information Form	Form	Modified	Repair queued
Form 0920-24DF Eligibility Screener Spanish	Form	Modified	Available
Form 0920-24DF Eligibility Screener English	Form	Modified	Available
Form 0920-24DF Eligibility Screener	Form	Modified	Available
MIC DROP burden table.docx	Supplementary Document	Uploaded 2024-04-03	Repair queued
Att 5a_Consent to Participate Spanish_clean.docx	Supplementary Document	Uploaded 2024-04-03	Repair queued
Att 5a_Consent to Participate English_clean.docx	Supplementary Document	Uploaded 2024-04-03	Repair queued
IRB approval for change to the study consent form.pdf	Supplementary Document	Uploaded 2024-04-03	Repair queued
IRB approval for change to the screener.pdf	Supplementary Document	Uploaded 2024-04-03	Repair queued
IRB approval for change to the in-depth interview consent form.pdf	Supplementary Document	Uploaded 2024-04-03	Repair queued
IRB approval for change to the focus group consent form.pdf	Supplementary Document	Uploaded 2024-04-03	Repair queued
IRB approval for change to the contact information form.pdf	Supplementary Document	Uploaded 2024-04-03	Repair queued
Justification and Summary of Changes 06Mar2024.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-04-03	Repair queued
Att 8_Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 7_Data Use Agreement.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 6d_San Diego State University IRB reliance agreement.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 6c_University of Chicago IRB reliance agreement.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 6b_Emory University IRB reliance agreement.pdf	Supplementary Document	Uploaded 2023-10-04	Available
Att 6a_WCG IRB Letter of Approval.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5c_In-Depth Interview Consent Spanish.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5c_In-Depth Interview Consent English.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5b_Focus Group Consent Spanish.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5b_Focus Group Consent English.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5a_Consent to Participate Spanish.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 5a_Consent to Participate English.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 3_Recruitment Materials Spanish.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 3_Recruitment Materials English.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 2a_60 Day FRN Pub11-16-2022.pdf	Supplementary Document	Uploaded 2023-10-04	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2023-10-04	Repair queued
SSB_MIC-DROP_29Aug2023.docx	Supporting Statement B	Uploaded 2023-10-04	Repair queued
SSA MIC DROP 29Aug2023_final.docx	Supporting Statement A	Uploaded 2023-10-04	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
262656	In-Depth Interview	Form	Modified	In-Depth Interview Consent Spanish
262656	In-Depth Interview	Form	Modified	In-Depth Interview Consent English
262656	In-Depth Interview	Form	Modified
262655	Focus Group Guide	Form	Modified	Att 5b_Focus Group Consent Spanish_clean
262655	Focus Group Guide	Form	Modified	Focus Group Consent English
262655	Focus Group Guide	Form	Modified
262654	STI Sample Collection	Form and Instruction	Unchanged	STI Sample Collection (Spanish)
262654	STI Sample Collection	Form and Instruction	Unchanged	STI Sample Collection
262654	STI Sample Collection	Form and Instruction	Unchanged
262653	HIV sample collection	Form and Instruction	Unchanged	HIV Sample Collection (Spanish)
262653	HIV sample collection	Form and Instruction	Unchanged	HIV Sample Collection
262653	HIV sample collection	Form and Instruction	Unchanged
262652	SMaRT App Install	Form and Instruction	Unchanged	SMART App Installation (Spanish)
262652	SMaRT App Install	Form and Instruction	Unchanged	SMART App Installation
262652	SMaRT App Install	Form and Instruction	Unchanged
262651	Quarterly Assessment	Form	Modified	Quarterly assessment Spanish
262651	Quarterly Assessment	Form	Modified	Quarterly assessment English
262651	Quarterly Assessment	Form	Modified
262650	Registration Contact Information Form	Form	Modified	Registration Contact Information Form Spanish
262650	Registration Contact Information Form	Form	Modified	Registration Contact Information Form English
262650	Registration Contact Information Form	Form	Modified
262642	Eligibility Screener	Form	Modified	Eligibility Screener Spanish
262642	Eligibility Screener	Form	Modified	Eligibility Screener English
262642	Eligibility Screener	Form	Modified

ICR Details

OMB Control No: 0920-1421	ICR Reference No: 202403-0920-004
Status: Historical Active	Previous ICR Reference No: 202310-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24DF
Title: [NCHHSTP] Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era
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 with change	Conclusion Date: 06/06/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/03/2024
Terms of Clearance: Approved consistent with the understanding that in the next revision/extension of the package, CDC will provide a justification to not use the more detailed Race and Ethnicity Question (selection of subcategories and write-ins) in its Supporting Statement A OR will instead opt to use the more detailed Question as outlined in OMB's SPD-15. Previous terms continue: Approved consistent with the understanding that when communicating findings from this collection, all publications will clearly describe the scope and limitations of the study findings.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2026	11/30/2026	11/30/2026
Responses	9,443	0	9,443
Time Burden (Hours)	4,332	0	4,332
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this study is to understand the use of preexposure prophylaxis (PrEP) and other HIV and sexually transmitted infections (STI) prevention interventions over time among men who have sex with men (MSM). The study will also identify the most effective PrEP messaging and other HIV and STI prevention messaging to increase protective behaviors among MSM.We are requesting changes in order to be more consistent and responsive to participants, and to adhere to the institutional requirements of the awardee of the cooperative grant, Emory University. These changes are consistent with stakeholder input and align with the goals and plans of this project.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 68696	11/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 69638	10/06/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

table that charts list of burden

IC Title	Form No.	Form Name
Eligibility Screener	0920-24DF, 0920-24DF	Eligibility Screener English ,   Eligibility Screener Spanish
Focus Group Guide	0920-24DF, 0920-24DF	Focus Group Consent English ,   Att 5b_Focus Group Consent Spanish_clean
HIV sample collection	n/a, n/a	HIV Sample Collection ,   HIV Sample Collection (Spanish)
In-Depth Interview	0920-24DF, 0920-24DF	In-Depth Interview Consent English ,   In-Depth Interview Consent Spanish
Quarterly Assessment	0920-24DF, 0920-24DF	Quarterly assessment English ,   Quarterly assessment Spanish
Registration Contact Information Form	0920-24DF, 0920-24DF	Registration Contact Information Form English ,   Registration Contact Information Form Spanish
SMaRT App Install	n/a, n/a	SMART App Installation ,   SMART App Installation (Spanish)
STI Sample Collection	n/a, n/a	STI Sample Collection ,   STI Sample Collection (Spanish)

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ICR Summary of Burden

table that charts list 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	9,443	9,443	0	0	0	0
Annual Time Burden (Hours)	4,332	4,332	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:

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Annual Cost to Federal Government: $1,583,732

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.     Yes

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

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Common Form ICR:  No

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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: 04/03/2024

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