Formative Research and Tool Development

Forms and Documents

Document Name	Status
Form 0920-0840 Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention's Website Form and Instruction	New
Form 0920-0840 Virtual Focus Groups with Primary Care Physicians and OBGYNs Form and Instruction	New
Form 0920-0840 Formative Evaluation of Professional Development Resources - Web Survey Form and Instruction	New
Form 0920-0840 Pathways: Qualitative Interviews with Post-Partum Women Associated with Congenital Syphilis Cases (Case Mothers) Form and Instruction	New
Health Communication Message Testing on Tuberculosis Form and Instruction	New
Att 10 List of Approved ICRs.docx Supplementary Document	2018-08-30
Att 9 Example Consent Form.docx Supplementary Document	2018-08-30
Att 8 DHAP ConfidAssurance.doc Supplementary Document	2018-08-30
Att 7 Example Group Interview Guide.doc Supplementary Document	2018-08-30
Att 6 Sample Screening Tool.doc Supplementary Document	2018-08-30
Att 5 Example Survey.doc Supplementary Document	2018-08-30
Att 4 Example Individual Interview Guide.doc Supplementary Document	2018-08-30
Att 3 Example Questions.doc Supplementary Document	2018-08-30
Att 2 60 Day FRN.pdf Supplementary Document	2018-08-30
Att 1 AuthLegislation.doc Supplementary Document	2018-08-30
SSB.docx Supporting Statement B	2018-08-30
SSA.docx Supporting Statement A	2018-08-30

IC Document Collections

IC ID	Document Title	Status
240757	Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention's Website Form and Instruction	New
238539	Virtual Focus Groups with Primary Care Physicians and OBGYNs Form and Instruction	New
237285	Assessment of Gonorrhea Case Interviewing in SSuN Sites Other-Interview Guide	New
235815	Formative Evaluation of Professional Development Resources - Web Survey Form and Instruction	New
235472	Pathways: Qualitative Interviews with Post-Partum Women Associated with Congenital Syphilis Cases (Case Mothers) Form and Instruction	New
235234	Health Communication Message Testing on Adolescent Health Other-Moderator Guide	New
235026	Health Communication Message Testing on Tuberculosis Form and Instruction	New

ICR Details

OMB Control No: 0920-0840	ICR Reference No: 201808-0920-023
Status: Active	Previous ICR Reference No: 201511-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0840
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: 10/19/2018
	Date Received in OIRA: 09/18/2018
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	10/31/2021	36 Months From Approved	01/31/2019
Responses	121,800	0	121,800
Time Burden (Hours)	46,516	0	46,516
Cost Burden (Dollars)	2,348,936	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:
	83 FR 17663	04/23/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 47173	09/18/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Pathways: Qualitative Interviews with Post-Partum Women Associated with Congenital Syphilis Cases (Case Mothers)	0920-0840, 0920-0840, 0920-0840	Recruitment Script ,   Interview Scheduling Script ,   Interview Guide
Assessment of Gonorrhea Case Interviewing in SSuN Sites
Health Communication Message Testing on Tuberculosis	none	Recruitment Screener
Formative Evaluation of Professional Development Resources - Web Survey	0920-0840	Formative Evaluation of Professional Development Resources - Web Survey
Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention's Website	0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840, 0920-0840	Screener Adult ,   Interview Healthcare Provider Guide A ,   Interview Adult Guide ,   Interview Healthcare Provider Guide B ,   Interview Public Health Professional Guide ,   Screener Healthcare Provider ,   Screener Public Health Professional
Health Communication Message Testing on Adolescent Health	none, none	Recruitment Screener ,   Professional Outreach Email and Screener
Virtual Focus Groups with Primary Care Physicians and OBGYNs	0920-0840, 0920-0840	Recruitment Screener ,   DISCUSSION GUIDE: Virtual Focus Groups with Primary Care Physicians and OBGYNs: Attitudes about Proposed Hepatitis C Screening Guidelines DVH 2019

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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)	2,348,936	0	0	2,348,936	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

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.     No

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.     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: 09/18/2018

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