Formative Research and Tool Development

Forms and Documents

Document Name	Status
Local Effectiveness Assessment Project (LEAP): A Case Study of a Local Jurisdiction Providing HIV Services to MSM Form and Instruction	New
Evaluating HIV/AIDS Focused Video Game for Young People Form	New
Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC) Form	New
Understanding Barriers and Facilitators to HIV Prevention, Care, and Treatment Form	New
Testing Brief Messages for Black and Latino MSM Form	New
Injection Behaviors Among Young Persons in Rural/Suburban Settings Form	New
Form 0920-0840 Feasibility of HIV Behavioral Surveillance for Young MSM Form and Instruction	New
Testing Messages for Black and Latino MSM Form and Instruction	New
Testing Solutions for Sampling Challenges for MMP Form	New
Informing the Development of Mobile Apps for HIV Prevention, Treatment & Care Form	New
Evaluation of HIV Self-Testing Among MSM in High Prevalence Cities (eSTAMP) Form	New
Development of a Motion Comic for HIV/STI Prevention Among Young People Ages 15-24 Phase 2 Form	New
Formative Research and Tool Development: Survey of HIV Medical Care Providers to Guide the Medical Monitoring Project Form	New
Att 9 DHAP ConfidAssurance.doc Supplementary Document	2013-01-31
Att 7 Example Group Interview Guide.doc Supplementary Document	2013-01-31
Att 6 Sample Screening Tool.doc Supplementary Document	2013-01-31
Att 5 Example Survey.doc Supplementary Document	2013-01-31
Att 4 Example Individual Interview Guide.doc Supplementary Document	2013-01-31
Att 3 Example Questions.doc Supplementary Document	2013-01-31
Att 2 - 60 day FRN.pdf Supplementary Document	2013-01-31
Att 1 AuthLegislation.doc Supplementary Document	2013-01-31
(ICROupdated) 0840 Generic 1-31-2013- SSA.doc Supporting Statement A	2013-01-31

IC Document Collections

IC ID	Document Title	Status
217215	Local Effectiveness Assessment Project (LEAP): A Case Study of a Local Jurisdiction Providing HIV Services to MSM Form and Instruction	New
215770	Evaluating HIV/AIDS Focused Video Game for Young People Form	New
214195	Pilot Test Study for the HIV Risk Reduction Educational Tool (HRRET) Other-HRRET Website Content	New
213098	Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC) Form	New
211515	Understanding Barriers and Facilitators to HIV Prevention, Care, and Treatment Form	New
211479	Testing Brief Messages for Black and Latino MSM Form	New
211298	Injection Behaviors Among Young Persons in Rural/Suburban Settings Form	New
209930	Feasibility of HIV Behavioral Surveillance for Young MSM Form and Instruction	New
209289	Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers Other-WORD	New
208435	Testing Messages for Black and Latino MSM Form and Instruction	New
207572	Testing Solutions for Sampling Challenges for MMP Form	New
207103	Informing the Development of Mobile Apps for HIV Prevention, Treatment & Care Form	New
206883	DSTP Assessment of STD Clinic Users Other-Consent	New
206753	Evaluation of HIV Self-Testing Among MSM in High Prevalence Cities (eSTAMP) Form	New
206398	CBO Needs Assessment for Preparedness and Resources for Support of Biomedical HIV Prevention Other-Pre-test Telephone Interview Script	New
206246	Development of a Motion Comic for HIV/STI Prevention Among Young People Ages 15-24 Phase 2 Form	New
205959	Formative Research and Tool Development: Survey of HIV Medical Care Providers to Guide the Medical Monitoring Project Form	New

ICR Details

OMB Control No: 0920-0840	ICR Reference No: 201301-0920-010
Status: Historical Active	Previous ICR Reference No: 200910-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 18699
Title: Formative Research and Tool Development
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/01/2013
	Date Received in OIRA: 01/31/2013
Terms of Clearance: Previous terms continue: OMB approves this umbrella generic, and has informed CDC that each individual study should be submitted into ROCIS an a ¿genIC¿ that includes the actual study instruments and a memo describing the specific study goal, the study design, any incentives to be used, and the sampling and analysis plans.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	01/31/2013
Responses	121,800	0	121,800
Time Burden (Hours)	46,516	0	46,516
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) requests approval for a revised generic information collection that supports formative research in HIV/AIDS, sexually transmitted diseases, tuberculosis, and viral hepatitis.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	77 FR 46094	08/02/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 71794	12/04/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
Pilot Test Study for the HIV Risk Reduction Educational Tool (HRRET)	None, None, None	Pilot Study HRRET Screener Survey ,   Pilot Test HRRET PRETEST Web-based Survey ,   Pilot Test HRRET POSTTEST Web-based Survey
Injection Behaviors Among Young Persons in Rural/Suburban Settings	none, none, none	Formative Research Study ,   Screener ,   Consent
Development of a Motion Comic for HIV/STI Prevention Among Young People Ages 15-24 Phase 2	none, none, none, none, none	Motion Comic Pre Test Survey ,   Motion Comic Focus Group Guide 2 ,   Motion Comic Screener ,   Motion Comic Post Test Survey ,   Motion Comic Focus Group Guide 1
Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers
Feasibility of HIV Behavioral Surveillance for Young MSM	0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840	Attachment 4_Recruitment Debriefing ,   Attachment 5_Eligibility Screener ,   Attachment 6_Behavioral Assessment ,   Attachment 7_Key informant interview ,   Attachment 8_Focus Group Interview ,   Attachment 9_Enumeration Interview ,   Attachment 10_Landing Page and Banner Ad
Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC)	None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None	Review Material Patient Adherence Brochure ,   Review Material Adherence Wall Poster ,   Review Material Risk Reduction MD Brochure ,   Review Material Patient Action Plan ,   Review Material Patient Risk Reduction Brochure ,   Review Material Retention Brochure MD ,   Review Material Patient Record Form ,   Review Material Retention Brochure Patient ,   Review Material Retention Poster ,   Review Material Gardner Study Reprint ,   Review Material Adherence Brochure MD ,   CME Promotion Card ,   Review Material Risk Reduction Poster Option ,   Provider Screening Instrument ,   Paper and Pencil Survey ,   Informed Consent Form ,   Provider Screening Instrument ,   Review Material-Envelope ,   Review Material Folder ,   Review Material Brouchure and Folding Instructions ,   Review Material Patient Baseline Screen
Local Effectiveness Assessment Project (LEAP): A Case Study of a Local Jurisdiction Providing HIV Services to MSM	None, None, None, None	Interview Guide - Public Policy Stakeholders ,   Interview Guide - Community Leaders ,   Interview Guide - Individual/Network ,   Key Participant Information Sheet and Consent Form
Testing Brief Messages for Black and Latino MSM	none, none, none, none, none, none	Eligibility Screener - English ,   Eligibility Screener -Spanish ,   Messages and Outcomes ,   Messages and Outcomes - Spanish ,   Assessment - English ,   Assessment - Spanish
Informing the Development of Mobile Apps for HIV Prevention, Treatment & Care	none, none, none, none, none, none, form, none, none, none, none, none, none, none, none, none, none	Screener ,   Screener High Risk ,   Screener HIV Providers ,   PLWH Guide ,   PLWH Guide Spanish ,   High Risk Guide ,   High Risk Guide Spanish ,   HC Providers Guide ,   Focus Group Assessment ,   Focus Group Assessment Spanish ,   End User Survey ,   Consent PLWH & High Risk ,   Consent PLWH & High Risk Spanish ,   Assent PLWH & High Risk ,   Consent HC Providers ,   Usability Consent ,   Usability Assent
Testing Solutions for Sampling Challenges for MMP	none, none	2a - Interview questionnaire - English ,   2b - interview questionnaire - Spanish
Testing Messages for Black and Latino MSM	none, none, none, none	Eligibility Screener ,   Eligibility Screener - Spanish Version ,   Focus Group/Interview Guide ,   Focus Group/Interview Guide - Spanish Version
DSTP Assessment of STD Clinic Users	none	DSTDP Assessment of STD Clinic Users
CBO Needs Assessment for Preparedness and Resources for Support of Biomedical HIV Prevention	None, none	Biomedical HIV Prevention Organizational Assessment Web-based Survey Screenshots ,   Consent Form
Understanding Barriers and Facilitators to HIV Prevention, Care, and Treatment	none, none, none, none, none, none, none, none, none, none, none, none, none, none, none, none, none, none, none	Provider Demographic Questionnaire ,   Provider interview guide ,   Study screener - English ,   Study screener - Spanish ,   Discordant partners screeners - English ,   Discordant partners screener - Spanish ,   Contact Information - English ,   Contact Information - Spanish ,   Discordant partners contact info - English ,   Discordant partner consent - Spanish ,   Discordant partners contact info - Spanish ,   PLWH interview guide - English ,   PLWH interview guide - Spanish ,   Discordant partners interview guide - English ,   Discordant partners interview guide - Spanish ,   Provider info sheet and consent ,   PLWH consent ,   PLWH consent - Spanish ,   Discordant partner consent - English
Formative Research and Tool Development: Survey of HIV Medical Care Providers to Guide the Medical Monitoring Project	none, none	MMP Provider Survey ,   MMP Provider Survey Web-based Application Screenshots
Evaluation of HIV Self-Testing Among MSM in High Prevalence Cities (eSTAMP)	none, none, none, none, none	Eligibility Screener ,   Registration ,   Baseline Survey ,   Reporting of Self-Test Results ,   Follow-up Survey
Evaluating HIV/AIDS Focused Video Game for Young People	none, none, none, none	Experimental Group Survey ,   Enrollment Day Survey ,   30 Day Post Survey ,   Demographic Screener

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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	121,800	121,800	0	0	0	0
Annual Time Burden (Hours)	46,516	46,516	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: $574,500

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 01/31/2013

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