Formative Research and Tool Development

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Administrative Questionnaire	Form	New	Available
Patient Questionnaire	Form	New	Available
Form 0920-0840 Interview Guide	Form	New	Available
Form 0920-0840 Interview Guide - Pregnant Women	Form and Instruction	New	Available
Form 0920-0840 Eligibility Sreener - Pregnant Women	Form and Instruction	New	Available
Form 0920-0840 Interview Guide - Prenatal Care Providers	Form and Instruction	New	Available
Form 0920-0840 Eligibility Screener - Prenatal Care Providers	Form and Instruction	New	Available
Survey Trans - screenshots	Form	New	Available
Survey AMSM - screenshots	Form	New	Available
Survey - word	Form	New	Available
Survey screener	Form	New	Available
Screenshots of Transgender Youth Focus Group Guide	Form	New	Available
Transgender Youth Focus Group Guide	Form and Instruction	New	Available
Screenshots of AMSM Focus Group Guide	Form	New	Available
AMSM Focus Group Guide	Form and Instruction	New	Available
Screener for Online AMSM and Transgender Focus Groups	Form	New	Available
Screener for In-person AMSM and Transgender Focus Groups	Form and Instruction	New	Available
Telephone Interview Guide	Form and Instruction	New	Available
Eligibility Screener	Form and Instruction	New	Available
Middle School Focus Group Guide	Form and Instruction	New	Available
Eligibility Screener	Form and Instruction	New	Available
Qualitative Interview Guide	Form and Instruction	New	Available
In-Depth Interview Guide	Form and Instruction	New	Available
Focus Group Guide	Form and Instruction	New	Available
Eligibility Screening Form - Reverification	Form and Instruction	New	Available
Contact Information Form - Online	Form and Instruction	New	Available
Eligibility Screening Form - Online	Form and Instruction	New	Available
Vulnerable Populations Project Key Informant Interview Guide	Form and Instruction	New	Available
Form 0920-16ML Att 8-Teacher Interview Consent Form	Form and Instruction	New	Available
Form 0920-16ML Att 5-High School Student Focus Group Guide	Form and Instruction	New	Available
Form 0920-16ML Att 4-Middle School Student Focus Group Guide	Form and Instruction	New	Available
Form 0920-16ML Att 2-Teacher Interview Guide	Form and Instruction	New	Available
Att 10 List of Approved GenICs.docx	Supplementary Document	Uploaded 2015-11-02	Repair queued
SSB Generic_0840_102315.docx	Supporting Statement B	Uploaded 2015-11-02	Available
Att 9 Example Consent Form.docx	Supplementary Document	Uploaded 2015-11-02	Available
Att 2B 60 DayFRN Comments.pdf	Supplementary Document	Uploaded 2015-11-02	Available
Att 8 DHAP ConfidAssurance.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 7 Example Group Interview Guide.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 6 Sample Screening Tool.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 5 Example Survey.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 4 Example Individual Interview Guide.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 3 Example Questions.doc	Supplementary Document	Uploaded 2015-11-02	Available
Att 2 60 Day FRN.pdf	Supplementary Document	Uploaded 2015-11-02	Available
Att 1 AuthLegislation.doc	Supplementary Document	Uploaded 2013-01-31	Available
SSA Generic_0840_110315.doc	Supporting Statement A	Uploaded 2015-11-03	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
232609	Assessment of STD Service Needs and Provisions	Form	New	Administrative Questionnaire
232609	Assessment of STD Service Needs and Provisions	Form	New	Patient Questionnaire
232126	Project Engage 2.0: Engaging Gay "Community" Activism for Syphilis Prevention	Other-WORD	New
231185	Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the MMP	Form	New	Interview Guide
231025	2018 Congenital Syphilis Study	Form and Instruction	New	Interview Guide - Pregnant Women
231025	2018 Congenital Syphilis Study	Form and Instruction	New	Eligibility Sreener - Pregnant Women
231025	2018 Congenital Syphilis Study	Form and Instruction	New	Interview Guide - Prenatal Care Providers
231025	2018 Congenital Syphilis Study	Form and Instruction	New	Eligibility Screener - Prenatal Care Providers
228661	Formative Tools for Addressing HIV Prevention Preferences among Adolescent MSM	Form	New	Survey Trans - screenshots
228661	Formative Tools for Addressing HIV Prevention Preferences among Adolescent MSM	Form	New	Survey AMSM - screenshots
228661	Formative Tools for Addressing HIV Prevention Preferences among Adolescent MSM	Form	New	Survey - word
228661	Formative Tools for Addressing HIV Prevention Preferences among Adolescent MSM	Form	New	Survey screener
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form	New	Screenshots of Transgender Youth Focus Group Guide
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form and Instruction	New	Transgender Youth Focus Group Guide
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form	New	Screenshots of AMSM Focus Group Guide
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form and Instruction	New	AMSM Focus Group Guide
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form	New	Screener for Online AMSM and Transgender Focus Groups
228556	Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	Form and Instruction	New	Screener for In-person AMSM and Transgender Focus Groups
226015	Project Engage: Engaging Gay "Community" Activism for Syphilis Prevention	Form and Instruction	New	Telephone Interview Guide
226015	Project Engage: Engaging Gay "Community" Activism for Syphilis Prevention	Form and Instruction	New	Eligibility Screener
225744	Middle School Perspectives on Sexual Health Education in Fort Worth Independent School District	Form and Instruction	New	Middle School Focus Group Guide
223954	Formative Research on Resilience and Transgender Youth	Form and Instruction	New	Eligibility Screener
223954	Formative Research on Resilience and Transgender Youth	Form and Instruction	New	Qualitative Interview Guide
221497	Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	Form and Instruction	New	In-Depth Interview Guide
221497	Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	Form and Instruction	New	Focus Group Guide
221497	Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	Form and Instruction	New	Eligibility Screening Form - Reverification
221497	Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	Form and Instruction	New	Contact Information Form - Online
221497	Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	Form and Instruction	New	Eligibility Screening Form - Online
220155	Examination of Jail and Prison Policies Related to STD Prevention	Form and Instruction	New	Vulnerable Populations Project Key Informant Interview Guide
219919	Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	Form and Instruction	New	Att 8-Teacher Interview Consent Form
219919	Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	Form and Instruction	New	Att 5-High School Student Focus Group Guide
219919	Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	Form and Instruction	New	Att 4-Middle School Student Focus Group Guide
219919	Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	Form and Instruction	New	Att 2-Teacher Interview Guide
219919	Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	Instruction	New

ICR Details

OMB Control No: 0920-0840	ICR Reference No: 201511-0920-001
Status: Historical Active	Previous ICR Reference No: 201301-0920-010
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: 01/26/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/16/2015
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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved	02/29/2016
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 data collection and evidence are developed using a multitude of information sources and short term qualitative interviewing and cognitive research techniques have been proven invaluable in the development of scientifically valid and population-appropriate methods, interventions, and instruments. The activities conducted under this information collection will be used to inform many aspects of surveillance, communications, health promotion, and research project development for the 4 priority diseases (HIV, STDs, TB, and viral hepatitis) as well as school and adolescent health.

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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:
	80 FR 36540	06/25/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 66007	10/28/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
2018 Congenital Syphilis Study	0920-0840, 0920-0840, 0920-0840, 0920-0840	Eligibility Screener - Prenatal Care Providers ,   Interview Guide - Prenatal Care Providers ,   Eligibility Sreener - Pregnant Women ,   Interview Guide - Pregnant Women
Assessment of STD Service Needs and Provisions	none, none	Patient Questionnaire ,   Administrative Questionnaire
Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)	n/a, n/a, n/a, n/a, n/a, n/a	Screener for In-person AMSM and Transgender Focus Groups ,   Screener for Online AMSM and Transgender Focus Groups ,   AMSM Focus Group Guide ,   Screenshots of AMSM Focus Group Guide ,   Transgender Youth Focus Group Guide ,   Screenshots of Transgender Youth Focus Group Guide
Development of a Mobile Messaging Intervention for Men who have Sex with Men: Formative Study	NA, NA, NA, NA, NA	Eligibility Screening Form - Online ,   Contact Information Form - Online ,   Eligibility Screening Form - Reverification ,   Focus Group Guide ,   In-Depth Interview Guide
Examination of Jail and Prison Policies Related to STD Prevention	NA	Vulnerable Populations Project Key Informant Interview Guide
Formative Research on Resilience and Transgender Youth	N/A, N/A	Qualitative Interview Guide ,   Eligibility Screener
Formative Tools for Addressing HIV Prevention Preferences among Adolescent MSM	none, none, none, none	Survey screener ,   Survey - word ,   Survey AMSM - screenshots ,   Survey Trans - screenshots
Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the MMP	0920-0840	Interview Guide
Middle School Perspectives on Sexual Health Education in Fort Worth Independent School District	N/A	Middle School Focus Group Guide
Project Engage 2.0: Engaging Gay "Community" Activism for Syphilis Prevention
Project Engage: Engaging Gay "Community" Activism for Syphilis Prevention	NA, NA	Eligibility Screener ,   Telephone Interview Guide
Student and Teacher Perspectives on Sexual Health Education in Fort Worth Independent School District	0920-16ML, 0920-16ML, 0920-16ML, 0920-16ML	Att 2-Teacher Interview Guide ,   Att 4-Middle School Student Focus Group Guide ,   Att 5-High School Student Focus Group Guide ,   Att 8-Teacher Interview Consent Form

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ICR Summary of Burden

table that charts list 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: $574,000

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: 11/16/2015

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