[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
In-Depth Interview	Form and Instruction	New	Repair queued
Focus Group Guide	Form and Instruction	New	Repair queued
STI Sample Collection	Form and Instruction	New	Repair queued
HIV sample collection	Form and Instruction	New	Repair queued
SMaRT App Install	Form and Instruction	New	Repair queued
Quarterly Assessment	Form and Instruction	New	Repair queued
Registration Contact Information Form	Form and Instruction	New	Missing upstream
Eligibility Screener	Form and Instruction	New	Available
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	Repair queued
Att 6a_WCG IRB Letter of Approval.pdf	Supplementary Document	Uploaded 2023-10-04	Missing upstream
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	Missing upstream
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 and Instruction	New
262655	Focus Group Guide	Form and Instruction	New
262654	STI Sample Collection	Form and Instruction	New
262653	HIV sample collection	Form and Instruction	New
262652	SMaRT App Install	Form and Instruction	New
262651	Quarterly Assessment	Form and Instruction	New
262650	Registration Contact Information Form	Form and Instruction	New
262642	Eligibility Screener	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202310-0920-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-23AQ
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/12/2023

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	9,443	0
Time Burden (Hours)	4,332	0
Cost Burden (Dollars)	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.

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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	n/a, n/a	Eligibility Screener ,   Eligibility Screener (Spanish)
Focus Group Guide	n/a, n/a	Focus Group Guide ,   Focus Group Guide (Spanish)
HIV sample collection	n/a, n/a	HIV Sample Collection ,   HIV Sample Collection (Spanish)
In-Depth Interview	n/a, n/a	In-Depth Interview Guide ,   In-Depth Interview Guide (Spanish)
Quarterly Assessment	n/a, n/a	Quarterly Assessment ,   Quarterly Assessment (Spanish)
Registration Contact Information Form	n/a, n/a	Registration Contact Information Form ,   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 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	9,443	0	0	9,443	0	0
Annual Time Burden (Hours)	4,332	0	0	4,332	0	0
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 New collection.

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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: 10/12/2023

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