[NCCDPHP] Evaluation of a Prostate Cancer Decision Aid

Forms and Documents

Document Name	Status
Form 0920-24CB Pre-exposure Survey Form	Unchanged
Form 0920-24CB Patient Eligibility Screener Form	Unchanged
Form 0920-24CB Provider Survey Form	Unchanged
Form 0920-24CB Clinic Coordinator Interview Form	Unchanged
Form 0920-24CB Post-clinic Survey Form	Unchanged
Form 0920-24CB User Experience Interview Form	Unchanged
Form 0920-24CB Usability Survey Form	Unchanged
Form 0920-24CB Post-exposure survey Form	Unchanged
Change Request for CDC Prostate Cancer Screening Decision Aid Randomized Controlled Trial_2025April17.docx Justification for No Material/Nonsubstantive Change	2025-05-08
Attachment 13_Approved Privacy Narrative.pdf Supplementary Document	2024-08-05
4_Prostate Cancer_SSB.docx Supporting Statement B	2024-08-05
Attachment 14_Institutional Review Board Approval.docx Supplementary Document	2024-08-02
Attachment 03_Evaluation Questions and Indicators.docx Supplementary Document	2024-08-02
Attachment 02_Study Design Graphic.pdf Supplementary Document	2024-08-02
Attachment 01_Authorizing Legislation.pdf Supplementary Document	2024-08-02
_List of Attachments_SSA & SSB.docx Supplementary Document	2024-08-02
3_Prostate Cancer_SSA.docx Supporting Statement A	2024-08-02

IC Document Collections

IC ID	Document Title	Status
269819	Pre-exposure Survey Form	Unchanged
269818	Patient Eligibility Screener Form	Unchanged
269817	Provider Survey Form	Unchanged
269807	Clinic Coordinator Interview Form	Unchanged
269805	Post-clinic Survey Form	Unchanged
269803	User Experience Interview Form	Unchanged
269802	Usability Survey Form	Unchanged
269801	Post-exposure survey Form	Unchanged

ICR Details

OMB Control No: 0920-1438	ICR Reference No: 202505-0920-004
Status: Received in OIRA	Previous ICR Reference No: 202407-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25-0104
Title: [NCCDPHP] Evaluation of a Prostate Cancer Decision Aid
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/14/2025

	Requested	Previously Approved
Expiration Date	08/31/2027	08/31/2027
Responses	3,974	3,974
Time Burden (Hours)	1,129	1,129
Cost Burden (Dollars)	0	0

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Abstract: To conduct a randomized controlled trial (RCT) to determine if CDC’s online, simulated, human decision aid module, Talk to Nathan About Prostate Cancer Screening (treatment arm), is effective in improving knowledge, overcoming health literacy barriers, and resolving decisional conflict compared to a standard decision aid (control arm 1) and standard education materials (control arm 2). Also, to identify barriers and best practices for incorporating Talk to Nathan About Prostate Cancer Screening into the flow of primary care practice.

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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:
	89 FR 5237	01/26/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 58740	07/19/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Clinic Coordinator Interview	0920-24CB	Clinic Coordinator Interviews_Interview Guide
Patient Eligibility Screener	0920-24CB, 0920-24CB	Patient Eligibility Screener_English ,   Patient Eligibility Screener_Spanish
Post-clinic Survey	0920-24CB, 0920-24CB	Post-Clinic Visit Survey_Online_English ,   Post-Clinic Visit Survey_Online_Spanish
Post-exposure survey	0920-24CB, 0920-24CB	Post Exposure Survey _English ,   Post Exposure Survey _Spanish
Pre-exposure Survey	0920-24CB, 0920-24CB	Pre-Exposure Survey_Online_English ,   Pre-Exposure Survey_Online_Spanish
Provider Survey	0920-24CB	Provider Survey
Usability Survey	0920-24CB, 0920-24CB	Usability Survey_Online_English ,   Usability Survey_Online_Spanish
User Experience Interview	0920-24CB, 0920-24CB	User Experience Interviews_Interview Guide_English ,   User Experience Interviews_Interview Guide_Spanish

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ICR Summary of Burden

	Total Request	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	3,974	3,974	0	0	0	0
Annual Time Burden (Hours)	1,129	1,129	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: This is a new collection requesting three years of approval for 1,129 hours per year.

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Annual Cost to Federal Government: $16,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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.     Yes

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? No

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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: 05/14/2025

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