Formative Research and Tool Development

Forms and Documents

Document Name	Status
2012 Case-Surveillance-Based-Sampling Questionnaire for the Medical Monitoring Project (MPP) Form and Instruction	New
Demonstration Project of HCV Rapid Testing in HIV Testing Settings and Development of Recruitment Strategies for the Web-based HIV Behavioral Survey among MSM Form	New
Field Assessment of a Comprehensive Manual for Hepatitis C Counseling and Testing Form	New
Assessing the Accuracy of Self-Report of HIV Testing Behavior Form	New
Usability Study of Medscape's Technology-based Panel Form	New
Development of a Motion Comic for HIV/STI Prevention among Young People Form	New
Assessment of QDS Data Coll. System and Dev't of HIV Prev. Decision Support Messages and Form. Research for the Web-based HIV Beh. Survey among MSM Form	New
HIV Testing Factors among Rural Black Men and Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth Form	New
MARI - Empowering Latinas to Lash Out Against AIDS (ELLAS) Form	New
Sexual risk-taking among young black men who have sex with men: exploring the social and situational contexts of HIV risk, prevention and treatment Form	New
Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation - Spanish version Form	New
National TB Lab Services Survey and Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation Form	New
DHAP_ConfidAssurance.doc Supplementary Document	2010-01-14
0920-08AG_Att3-Ques.doc Supplementary Document	2009-09-21
092008AG_att2A-B_60dayFRN.doc Supplementary Document	2009-09-08
092008AG_Att1_AuthLegis.doc Supplementary Document	2009-09-08
comm_VPS_Generic- SSA.doc Supporting Statement A	2010-01-14

IC Document Collections

IC ID	Document Title	Status
205155	Evaluation of Rapid HIV Self-Testing: Qualitative and User Proficiency Assessments Other-WORD	New
203775	2012 Case-Surveillance-Based-Sampling Questionnaire for the Medical Monitoring Project (MPP) Form and Instruction	New
201871	Local Needs Assessment of Program Collaboration and Service Integration Among Infectious Disease Prevention Providers for Persons Who Use Drugs Illicitly Instruction	New
201422	Demonstration Project of HCV Rapid Testing in HIV Testing Settings and Development of Recruitment Strategies for the Web-based HIV Behavioral Survey among MSM Form	New
201009	Field Assessment of a Comprehensive Manual for Hepatitis C Counseling and Testing Form	New
200047	Assessing the Accuracy of Self-Report of HIV Testing Behavior Form	New
198960	Usability Study of Medscape's Technology-based Panel Form	New
198793	Development of a Motion Comic for HIV/STI Prevention among Young People Form	New
198250	Assessment of QDS Data Coll. System and Dev't of HIV Prev. Decision Support Messages and Form. Research for the Web-based HIV Beh. Survey among MSM Form	New
195746	HIV Testing Factors among Rural Black Men and Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth Form	New
194859	MARI - Empowering Latinas to Lash Out Against AIDS (ELLAS) Form	New
193928	Sexual risk-taking among young black men who have sex with men: exploring the social and situational contexts of HIV risk, prevention and treatment Form	New
193547	Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation - Spanish version Form	New
192789	National TB Lab Services Survey and Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation Form	New

ICR Details

OMB Control No: 0920-0840	ICR Reference No: 200910-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Formative Research and Tool Development
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: 01/15/2010
	Date Received in OIRA: 10/16/2009
Terms of Clearance: 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	01/31/2013	36 Months From Approved
Responses	121,800	0	0
Time Burden (Hours)	46,516	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) requests approval for a new 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:
	74 FR 10591	03/11/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 46199	09/08/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
MARI - Empowering Latinas to Lash Out Against AIDS (ELLAS)	none, none, none, none	Screener ,   Group Interview ,   Survey of Individual ,   Health Care Provider Interview
Assessment of QDS Data Coll. System and Dev't of HIV Prev. Decision Support Messages and Form. Research for the Web-based HIV Beh. Survey among MSM	none, none, none, none, none, none, none, none, none, none	Assessment - Survey ,   Assessment - Screener ,   Message Testing - interview screener ,   Message Testing - Qualitative interview ,   Message Testing - Survey screener ,   Message Testing - Web-based Survey ,   Web-based Survey - Web Survey Screener ,   Web-based Survey - Focus Group Screener ,   Web-based Survey - Focus Group Interview ,   Web-based Survey - Web Survey Questionnaire
Demonstration Project of HCV Rapid Testing in HIV Testing Settings and Development of Recruitment Strategies for the Web-based HIV Behavioral Survey among MSM	none, none, none, none, none, none, none, none, none	HCV Testing - Denver screener ,   Recruitment - 1a Screener ,   HCV Testing - Focus Group Guide ,   HCV Testing - Screener ,   Recruitment - 1b Focus Group Interview ,   Recruitment - 1c Screener ,   Recruitment - 1d Web Survey ,   Recruitment - 3a Spanish Screener ,   Recruitment - 3b Spanish Survey
Evaluation of Rapid HIV Self-Testing: Qualitative and User Proficiency Assessments
Sexual risk-taking among young black men who have sex with men: exploring the social and situational contexts of HIV risk, prevention and treatment	none, none, none, none	Screener ,   ACASI survey ,   Web-based sex diary ,   In-depth interview
National TB Lab Services Survey and Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation	none, none, none	National TB Lab Services Survey ,   Assessment of QDS System-screener ,   Assessment of QDS System - survey
Usability Study of Medscape's Technology-based Panel	none, none	Screener ,   Questionnaire
Development of a Motion Comic for HIV/STI Prevention among Young People	none, none, none, none, none, none	Study screener ,   Phase 1 focus group guide ,   Phase 3 focus group guide ,   Phase 2 focus group guide ,   Pre-test survey ,   Post-test Survey
Local Needs Assessment of Program Collaboration and Service Integration Among Infectious Disease Prevention Providers for Persons Who Use Drugs Illicitly
HIV Testing Factors among Rural Black Men and Family and Cultural Impact on STD and HIV Risk among Latino and African-American Youth	none, none, none, none, none, none, none, none	Screener - Testing in Rural Black Men ,   Adolescent survey - Family and Cultural Impact ,   Survey - Testing in Rural Black Men ,   Focus group guide - Testing in Rural Black Men ,   Focus group guide - Family and Cultural Impact ,   Focus group screener - Family and Cultural Impact ,   Survey screener - Family and Cultural Impact ,   Adult survey - Family and Cultural Impact
2012 Case-Surveillance-Based-Sampling Questionnaire for the Medical Monitoring Project (MPP)	None, OMB 0920-0740 - Medical History Form, OMB 0920-0840 Surveillance Period Summary Form, OMB 0920-0740 Surveillance Period Visit Form, 0920-0740 Surveillance Period Inpatient Form, None, None	2012 Case-Surveillance-Based-Sampling Questionnaire for The Medical Monitoring Project (MMP) ,   Medical Record Abstraction Form ,   Surveillance Period Summary Form ,   Surveillance Period Visit Form ,   Surveillance Period Inpatient Form ,   2012 CSBS Process Documentation Form ,   Model Patient Recruitment Script
Field Assessment of a Comprehensive Manual for Hepatitis C Counseling and Testing	none, none, none	Recruitment Script ,   Interview ,   Check-in Questions
Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation - Spanish version	none, none	Eligibility screener - Spanish version ,   Baseline survey - Spanish version
Assessing the Accuracy of Self-Report of HIV Testing Behavior	none, none, none	Medical Record Abstraction ,   Consent Form ,   Patient Survey

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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	0	0	121,800	0	0
Annual Time Burden (Hours)	46,516	0	0	46,516	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 generic data collection.

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 10/16/2009

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