CDC/ATSDR Formative Research and Tool Development

Forms and Documents

Document	Type	Status	Availability
Form 0920-1154 Determination of Attitudes Regarding Noise in Construction	Form and Instruction	New	Available
Form 0920-1154 Participatory Mapping to Identify and Support At-Risk Populations in Emergency Preparedness – Phase 3	Form and Instruction	New	Available
Formative Research to Identify Common and Unique Barriers to the Exchange of Hospitalization and ED Data	Form	New	Available
Reaching Minority Men Where They Are – Formative Research to Build Capacity for Enrollment in Diabetes Prevention and Management Programs	Form and Instruction	New	Available
Form 0920-1154 Formative Research to Develop an Open Data Standard for Reporting Environmental Health Data	Form and Instruction	New	Available
Form 0920-1154 Ethnicity & Race: Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy	Form and Instruction	New	Available
Focus Groups of US Adults KAP of Foodborne Disease Outbreaks and Illness Prevention	Form and Instruction	New	Available
Form 0920-1154 BRFSS Feasibility Experiment for State-specific Module Data Collection in Cell Phone Samples	Form and Instruction	New	Available
Form 0920-1154 Federal Select Agent Program eFSAP Feedback Survey	Form	New	Available
Form 0920-1154 Older Adult Mobility Ride Share (OAMRS)	Form and Instruction	New	Available
Core Elements of Antimicrobial Stewardship in Nursing Homes	Form	New	Available
Form 0920-1154 Behavioral Determinants of Community Hand Hygiene Behavior: A Formative Qualitative Evaluation	Form	New	Available
CDC's Inside Knowledge Campaign: 2018 Focus Group Research and Testing with the General Public and Hispanic Audiences	Form and Instruction	New	Available
Increase Enrollment in the CDC-Recognized Lifestyle Change Program (LCP)	Form and Instruction	New	Available
Form 0920-1154 Disability and Health Data System Evaluaton Survey	Form and Instruction	New	Available
Formative Research to Assess Pediatric Healthcare Providers Knowledge, Attitudes and Practices around Zika Virus	Form	New	Available
Form 0920-1154 Assessment of the Zika Care Connect Program	Form and Instruction	New	Available
Persuasive Communication about Risks from and Responses to Zika: FOCUS GROUPS	Form and Instruction	New	Available
Antibiotic Stewardship in Hospitals Assessment	Form	New	Available
Formative Evaluation for Shigellosis Sexual Health Materials for Men who have Sex with Men	Form	New	Available
Persuasive Communication about Risks from and Responses to Zika – State, Local and Tribal Government Interviews	Form and Instruction	New	Available
Formative Assessment of Barriers to Transition from Adolescent to Adult for Individuals with Congenital Heart Defects	Form	New	Available
Reframing How We Talk About Alcohol	Form and Instruction	New	Available
Formative Research for Sepsis and Antibiotic Use Campaigns	Form	New	Available
GenICRequestTemplate.docx	Supplementary Document	Uploaded 2016-10-20	Available
60dayFRN.pdf	Supplementary Document	Uploaded 2016-10-20	Available
AuthLegislation.doc	Supplementary Document	Uploaded 2016-10-20	Available
SSB.docx	Supporting Statement B	Uploaded 2016-10-20	Available
ATSDR Formative Research and Tool Development Generic_OMB.doc	Supporting Statement A	Uploaded 2017-01-19	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
239014	Determination of Attitudes Regarding Noise in Construction	Form and Instruction	New
238970	Participatory Mapping to Identify and Support At-Risk Populations in Emergency Preparedness – Phase 3	Form and Instruction	New
238392	Formative Research to Inform an Intervention to Improve Early Detection and Surveillance of Pneumoconiosis in US Coal Miners	Other-Interview guide	New
238224	Formative Assessment of the Information Needs to Prevent Skin Cancer Among Spanish speaking Outdoor Workers	Other-Focus Group Guide	New
237867	2019 Updated B Reader Certification Examination	Other-Screenshots	New
237140	Formative Research to Identify Common and Unique Barriers to the Exchange of Hospitalization and ED Data	Form	New
236579	Formative Assessment of the Information Needs to Prevent Work-related Musculoskeletal Disorders and Falls among Aging Retail Workers	Other-Focus group guide	New
236556	Reaching Minority Men Where They Are – Formative Research to Build Capacity for Enrollment in Diabetes Prevention and Management Programs	Form and Instruction	New
236243	Formative Research to Develop an Open Data Standard for Reporting Environmental Health Data	Form and Instruction	New
235993	Ethnicity & Race: Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy	Form and Instruction	New
235328	Focus Groups of US Adults KAP of Foodborne Disease Outbreaks and Illness Prevention	Form and Instruction	New
235305	BRFSS Feasibility Experiment for State-specific Module Data Collection in Cell Phone Samples	Form and Instruction	New
234224	Clinician Preferences for CDC Clinical Guidelines	Other-WORD	New
233456	Formative Research with Clinicians for the Development of Quantitative Metrics to Improve Antibiotic Prescribing Behavior in the Outpatient Setting	Other-WORD	New
232735	Federal Select Agent Program eFSAP Feedback Survey	Form	New
232408	Participatory Mapping to Identy and Support at Risk Population in Emergency Preparedness -- Phase 2	Other-WORD	New
231946	Older Adult Mobility Ride Share (OAMRS)	Form and Instruction	New
231812	Core Elements of Antimicrobial Stewardship in Nursing Homes	Form	New
231343	Behavioral Determinants of Community Hand Hygiene Behavior: A Formative Qualitative Evaluation	Form	New
231333	FORMATIVE RESEARCH TO DEVELOP ZIKA TOOLS FOR HEALTHCARE PROVIDERS	Other-Focus Group Discussion Guide - OB-GYN/PEDS/MIDWIVES/NPs	New
231332	CDC's Inside Knowledge Campaign: 2018 Focus Group Research and Testing with the General Public and Hispanic Audiences	Form and Instruction	New
231069	Increase Enrollment in the CDC-Recognized Lifestyle Change Program (LCP)	Form and Instruction	New
230837	Disability and Health Data System Evaluaton Survey	Form and Instruction	New
230823	Zika Family Survey: In-Depth Interviews with Women Affected by Zika Virus	Instruction	New
230045	Formative Research to Assess Pediatric Healthcare Providers Knowledge, Attitudes and Practices around Zika Virus	Form	New
229528	Assessment of the Zika Care Connect Program	Form and Instruction	New
228512	Persuasive Communication about Risks from and Responses to Zika: FOCUS GROUPS	Form and Instruction	New
227942	BRFSS Preliminary Experiment for Sample and Mode	Other-WORD	New
227437	Antibiotic Stewardship in Hospitals Assessment	Form	New
226670	Formative Evaluation for Shigellosis Sexual Health Materials for Men who have Sex with Men	Form	New
226552	Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness	Other-Interview Guide	New
226486	Persuasive Communication about Risks from and Responses to Zika – State, Local and Tribal Government Interviews	Form and Instruction	New
226379	Formative Assessment of Barriers to Transition from Adolescent to Adult for Individuals with Congenital Heart Defects	Form	New
226269	Reframing How We Talk About Alcohol	Form and Instruction	New
225603	Formative Research for Sepsis and Antibiotic Use Campaigns	Form	New

ICR Details

OMB Control No: 0920-1154	ICR Reference No: 201610-0920-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16AVC
Title: CDC/ATSDR 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: 01/19/2017
	Date Received in OIRA: 10/26/2016
Terms of Clearance: OMB approves this umbrella generic, and has informed CDC/ATSDR that each individual study should be submitted into ROCIS an a genIC that includes full supporting statement Part A and an accompanying Supporting Statement Part B if any statistical methods are employed for sampling or analyses of data. A complete justification for any incentives offered to respondents will also accompany all substudies submitted under this Generic. Outcomes collected under this generic pathway are intended for internal ATSDR use only and will not be generalized beyond the scope of each study or to broader populations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved
Responses	60,000	0	0
Time Burden (Hours)	56,250	0	0
Cost Burden (Dollars)	1,125,000	0	0

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Abstract: CDC proposes a new generic clearance to conduct formative research for developing new tools and methodologies to support agency research, surveillance, and program evaluation activities, and the development and assessment of multi-use tools.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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:
	81 FR 46680	07/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 73112	10/24/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 35

IC Title	Form No.	Form Name
BRFSS Preliminary Experiment for Sample and Mode
Increase Enrollment in the CDC-Recognized Lifestyle Change Program (LCP)	NA, NA, NA, NA	Pre-Session Survey ,   Post-Session Survey ,   Enrollment Materials and Referral Tracking Form ,   LCP Staff/Coach Interview Guide
Federal Select Agent Program eFSAP Feedback Survey	0920-1154, 0920-1154	FSAP Survey System Enhancement ,   FSAP User Experience Survey
Formative Research with Clinicians for the Development of Quantitative Metrics to Improve Antibiotic Prescribing Behavior in the Outpatient Setting
Formative Research to Identify Common and Unique Barriers to the Exchange of Hospitalization and ED Data	none, none, none	Survey ,   Survey - word ,   Survey prenotice
Formative Assessment of the Information Needs to Prevent Skin Cancer Among Spanish speaking Outdoor Workers
Formative Research for Sepsis and Antibiotic Use Campaigns	none, none, none, none, none, none, none, none, none, none, none, none, none, none, none	Sepsis Consumer Screener - mothers ,   Sepsis Consumer Screener - healthy adults 65+ ,   Sepsis Consumer Screener - AA men ,   HCP Sepsis Screener - ED triage nurse ,   HCP Sepsis Screener - NP or PA ,   HCP Sepsis Screener - PCP ,   HCP Sepsis Screener - Gen med ward ,   Consumer Interview Sepsis ,   HCP Interview Sepsis ,   HCP Antibiotic Use Screener ,   Consumer Screener - SD-SE ,   Consumer Screener - CD - CE ,   HCP Antibiotic Use Interview ,   Consumer Interview - SE - SD ,   Consumer Interview - CE - CD
Formative Evaluation for Shigellosis Sexual Health Materials for Men who have Sex with Men	none	Screener
Disability and Health Data System Evaluaton Survey	0920-1154	Disability and Halth Data System Evaulation Survey
Formative Assessment of Barriers to Transition from Adolescent to Adult for Individuals with Congenital Heart Defects	none	Survey of Parents of Adolescents with Congenital Heart Defects
Participatory Mapping to Identy and Support at Risk Population in Emergency Preparedness -- Phase 2
Formative Research to Develop an Open Data Standard for Reporting Environmental Health Data	0920-1154	Key Informant Interview Plan
Reframing How We Talk About Alcohol	none	Screener
FORMATIVE RESEARCH TO DEVELOP ZIKA TOOLS FOR HEALTHCARE PROVIDERS	0920-1154, 0920-1154, 0920-1154	ACOG Zika Virus Survey ,   Focus Group Recruitment Screen ,   ACOG Evaluation of Local Health Department Initiative
Zika Family Survey: In-Depth Interviews with Women Affected by Zika Virus	0920-1154	IN-DEPTH INTERVIEWS WITH WOMEN AFFECTED BY THE ZIKA VIRUS - INTERVIEW GUIDE
Participatory Mapping to Identify and Support At-Risk Populations in Emergency Preparedness – Phase 3	0920-1154	Survey Disaster Planners
Formative Assessment of the Information Needs to Prevent Work-related Musculoskeletal Disorders and Falls among Aging Retail Workers
Formative Research to Inform an Intervention to Improve Early Detection and Surveillance of Pneumoconiosis in US Coal Miners	none, none, none	Interview demographic survey ,   Focus group demographic survey ,   Interview sign-up
Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness
Persuasive Communication about Risks from and Responses to Zika: FOCUS GROUPS	NA	Focus Group - Vignette
CDC's Inside Knowledge Campaign: 2018 Focus Group Research and Testing with the General Public and Hispanic Audiences	n/a, n/a, n/a, n/a	English Language Screening Instrument ,   Spanish Language Screening Instrument ,   English Language Focus Group Discussion Guide ,   Spanish Language Focus Group Discussion Guide
Behavioral Determinants of Community Hand Hygiene Behavior: A Formative Qualitative Evaluation	0920-1154, 0920-1154	Online Screener ,   Focus Group Moderator Guide
Ethnicity & Race: Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy	0920-1154, 0920-1154, 0920-1154, 0920-1154	Consent Form Provider (Online Survey) ,   Consent Form Provider In-Depth Interview ,   Consent Form Women In-Depth Interview ,   Provider Screener and Online Survey
Reaching Minority Men Where They Are – Formative Research to Build Capacity for Enrollment in Diabetes Prevention and Management Programs	n/a, n/a, n/a, n/a, n/a	Focus Group Guide: Minority Men at Risk for Type 2 Diabetes ,   Focus Group Guide: Minority Men Diagnosed with Type 2 Diabetes ,   Screener ,   Initial Screen Shot of the Web-based Survey (with OMB control information) ,   Survey (content)
Assessment of the Zika Care Connect Program	0920-1154, 0920-1154, 0920-1154, 0920-1154, 0920-1154	Invitation Email to access Survey - Health Care Professional ,   Reminder Invitation Email to access Survey - Health Care Professional ,   Survey - Healthcare Professional ,   Pop-Up Invitation to Survey - Website User ,   Survey - Website User
Older Adult Mobility Ride Share (OAMRS)	0920-1154, 0920-1154, 0920-1154, 0920-1154, 0920-1154, 0920-1154, 0920-1154	Written Questionnaire Focus Group ,   Focus Group Protocol - Users ,   Focus Group Protocol - Non-Users ,   Interview Protocol - Users ,   Interview Protocol - Non-Users ,   Screener Focus Group ,   Screener Telephone Interview
Clinician Preferences for CDC Clinical Guidelines
Formative Research to Assess Pediatric Healthcare Providers Knowledge, Attitudes and Practices around Zika Virus	none	Survey of Experiences with and Attitudes towards Zika Virus
Core Elements of Antimicrobial Stewardship in Nursing Homes	none	Prescriber Assessment
BRFSS Feasibility Experiment for State-specific Module Data Collection in Cell Phone Samples	0920-1154	Questionnaire Content
Focus Groups of US Adults KAP of Foodborne Disease Outbreaks and Illness Prevention	none, none	Recruitment Screener ,   Recruitment Follow-up Contact
2019 Updated B Reader Certification Examination
Determination of Attitudes Regarding Noise in Construction	0920-1154, 0920-1154, 0920-1154, 0920-1154	Construction Industry Executive/Decision-Maker In-Depth Interviews ,   Construction Supervisor/Foreman Focus Group ,   Construction Workers Focus Groups (ENGLISH) ,   Construction Workers Focus Groups (SPANISH)
Persuasive Communication about Risks from and Responses to Zika – State, Local and Tribal Government Interviews	NA	Interview Guide - Public Health Officials
Antibiotic Stewardship in Hospitals Assessment	none, none	Hospital Antibiotic Stewardship Core Element Assessment ,   Feedback Questionnaire

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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	60,000	0	0	60,000	0	0
Annual Time Burden (Hours)	56,250	0	0	56,250	0	0
Annual Cost Burden (Dollars)	1,125,000	0	0	1,125,000	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 ICR.

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Annual Cost to Federal Government: $474,091

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: 10/26/2016

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