Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men

Forms and Documents

Document Name	Status
Behavioral Assessment Form and Instruction	New
Eligibility Verification Form and Instruction	New
Focus Group Moderator Guide Form and Instruction	New
In-Depth Interview Guide Form and Instruction	New
Contact Form Form and Instruction	New
Screener Form and Instruction	New
SSB.docx Supporting Statement B	2018-09-07
SSA.docx Supporting Statement A	2018-09-07
Att 8 PIA 17AZI.pdf Supplementary Document	2018-09-06
Att 7 Data Security Plan.docx Supplementary Document	2018-09-06
Att 6 Recruitment materials.pdf Supplementary Document	2018-09-06
Att 5b CDC IRB Approval.docx Supplementary Document	2018-09-06
Att 5a Emory IRB Decision.pdf Supplementary Document	2018-09-06
Att 4c Behavioral Assessment Informed Consent.docx Supplementary Document	2018-09-06
Att 4b Focus Group Informed Consent.docx Supplementary Document	2018-09-06
Att 4a In-depth Interview Informed Consent.doc.docx Supplementary Document	2018-09-06
Att 2 60-Day FRN.pdf Supplementary Document	2018-09-06
Att 1 Auth Legislation.docx Supplementary Document	2018-09-06

IC Document Collections

IC ID	Document Title	Status
232944	Behavioral Assessment Form and Instruction	New
232943	Eligibility Verification Form and Instruction	New
232940	Focus Group Moderator Guide Form and Instruction	New
232938	In-Depth Interview Guide Form and Instruction	New
232933	Contact Form Form and Instruction	New
232929	Screener Form and Instruction	New

ICR Details

OMB Control No: 0920-1245	ICR Reference No: 201808-0920-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17AZI
Title: Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/19/2018
	Date Received in OIRA: 09/25/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	12 Months From Approved
Responses	1,620	0	0
Time Burden (Hours)	335	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this research is to explore decisions, barriers, and facilitators about pre-exposure prophylaxis (PrEP) use (PrEP is an FDA-approved regimen of Tenofovir/emtricitabine), shown to have greater than 90% efficacy in reducing HIV infections among men who have sex with men (MSM) when taken in accordance with its prescribed daily schedule) among MSM: 1) who were offered PrEP but refused it; 2) who were interested in or started a PrEP regimen but did not follow through; and (3) who are eligible for PrEP per CDC guidelines (report condomless anal sex within last 3 months).

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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:
	82 FR 46996	10/10/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45442	09/07/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Behavioral Assessment	NA	Self-Administered Behavioral Assessment
Contact Form	NA	PrEP Project Contact Form
Focus Group Moderator Guide	NA	PrEP Focus Group Moderator Guide
In-Depth Interview Guide	NA	PrEP Semi-Structured In-Depth Interview Guide
Screener	NA	PrEP Project Screener
Eligibility Verification	NA	Verificatgion of Eligibility

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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	1,620	0	0	1,620	0	0
Annual Time Burden (Hours)	335	0	0	335	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: Submission of 0920-17AZI - Understanding Decisions and Barriers about PrEP Use and Uptake Among Men Who Have Sex With Men is a New ICR.

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Annual Cost to Federal Government: $474,083

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.     Yes

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? Uncollected

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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: 09/25/2018

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