Understanding Barriers and Facilitators to HIV Prevention for Men who Have Sex with Men (MSM) - Pulse Study

Forms and Documents

Document Name	Status
Form 0920-15AGK HIV-negative In-Depth Interview Guide Minors-Spanish Form and Instruction	New
Form 0920-15AGK HIV-negative In-Depth Interview Guide General Public Adults -Spanish Form and Instruction	New
Form 0920-15AGK Att 3e HIV-Neg MSM In-depth Int_English Form and Instruction	New
Form 0920-15AGK HIV-negative MSM In-Depth Interview Guide Adults -English Form and Instruction	New
Form 0920-15AGK HIV-negative MSM Contact Information Form-Spanish Form and Instruction	New
Form 0920-15AGK HIV-negative MSM Contact Information Form-English Form and Instruction	New
Form 0920-15AGK HIV-negative MSM Screener-Spanish Form and Instruction	New
Form 0920-015AGK HIV-negative MSM Screener-English Form and Instruction	New
Task 6.2 Study Protocol v4.0.docx Supplementary Document	2015-11-25
Pulse ProjDeterm.pdf Supplementary Document	2015-11-25
Att 9 Certificate of Confidentiality.pdf Supplementary Document	2015-11-25
Att 8 Data Security Plan.docx Supplementary Document	2015-11-25
Att 7 Spanish Translation Cert.pdf Supplementary Document	2015-11-25
Att 5e Emory University IRB Approval Amendment 6.18.15.pdf Supplementary Document	2015-11-25
Att 5d Emory University IRB Approval Amendment 4.24.15.pdf Supplementary Document	2015-11-25
Att 5c Emory RSS IAA Agreement 77517.pdf Supplementary Document	2015-11-25
Att 5b Emory Univ IRB Amendment 1.pdf Supplementary Document	2015-11-25
Att 5a Emory Univ IRB Approval Letter.pdf Supplementary Document	2015-11-25
Att 4d HIV-Neg MSM Assent Form_Spanish.docx Supplementary Document	2015-11-25
Att 4c HIV-Neg MSM Assent Form_English.docx Supplementary Document	2015-11-25
Att 4b HIV-Neg MSM Consent Form_Spanish.docx Supplementary Document	2015-11-25
Att 4a HIV-Neg MSM Consent Form_English.docx Supplementary Document	2015-11-25
Supporting Statement B.docx Supporting Statement B	2015-11-25
SSA Clean_MSM Pulse Study.docx Supporting Statement A	2016-04-01

IC Document Collections

IC ID	Document Title	Status
219093	HIV-negative In-Depth Interview Guide Minors-Spanish Form and Instruction	New
219092	HIV-negative In-Depth Interview Guide General Public Adults -Spanish Form and Instruction	New
219091	Att 3e HIV-Neg MSM In-depth Int_English Form and Instruction	New
219090	HIV-negative MSM In-Depth Interview Guide Adults -English Form and Instruction	New
219089	HIV-negative MSM Contact Information Form-Spanish Form and Instruction	New
219088	HIV-negative MSM Contact Information Form-English Form and Instruction	New
219087	HIV-negative MSM Screener-Spanish Form and Instruction	New
219086	HIV-negative MSM Screener-English Form and Instruction	New
219085	State and Health Dept. CBO Recruitment Flyer- English and Spanish Instruction	New

ICR Details

OMB Control No: 0920-1111	ICR Reference No: 201511-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15AGK
Title: Understanding Barriers and Facilitators to HIV Prevention for Men who Have Sex with Men (MSM) - Pulse Study
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 with change	Conclusion Date: 04/06/2016
	Date Received in OIRA: 11/30/2015
Terms of Clearance: Approved consistent with the understanding that this collection entails a qualitative study that will not be comparing outcomes between groups/cities or generalizing information to broader populations in the United States.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved
Responses	900	0	0
Time Burden (Hours)	184	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study seeks to provide understanding on the many factors that prevent some men who have sex with men (MSM) and young MSM (YMSM) from contracting HIV. We will qualitatively examine how socio-geo-demographic factors such as HIV risk perception, perceptions of community relationships and social support serve as contributors and inhibitors to remaining HIV negative.

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Authorizing Statute(s): Statute at Large: 301 Stat. 241 Name of Statute: General Powers and Duties of Public Health Service
  

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:
	80 FR 27316	05/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 72436	11/19/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
HIV-negative MSM Contact Information Form-Spanish	0920-15AGK	Att 3d HIV-Neg MSM Contact Info_Spanish
HIV-negative In-Depth Interview Guide General Public Adults -Spanish	0920-15AGK	Att 3f HIV-Neg MSM In-depth Int_Spanish
HIV-negative MSM Screener-English	0920-015AGK	Att 3a HIV-Neg MSM Screener_English
HIV-negative MSM Screener-Spanish	0920-15AGK	Att 3b HIV-Neg MSM Screener_Spanish
HIV-negative MSM Contact Information Form-English	0920-15AGK	Att 3c HIV-Neg MSM Contact Info_English
HIV-negative MSM In-Depth Interview Guide Adults -English	0920-15AGK	Att 3e HIV-Neg MSM In-depth Int_English
Att 3e HIV-Neg MSM In-depth Int_English	0920-15AGK	Att 3e HIV-Neg MSM In-depth Int_English
State and Health Dept. CBO Recruitment Flyer- English and Spanish
HIV-negative In-Depth Interview Guide Minors-Spanish	0920-15AGK	Att 3f HIV-Neg MSM In-depth Int_Spanish

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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	900	0	0	900	0	0
Annual Time Burden (Hours)	184	0	0	184	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: New ICR, no changes

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Annual Cost to Federal Government: $548,166

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? 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: 11/30/2015

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