The Centers for Disease Control and Prevention (CDC) Study on Disparities in Distress Screening among Lung and Ovarian Cancer Survivors

Forms and Documents

Document Name	Status
Form 0920-19MM Focus Groups Form and Instruction	New
Form 0920-19MM Key Informant Interview Guide and Consent Form and Instruction	New
Form 0920-19MM EHR Data Form and Instruction	New
Privacy Narrative Cancer Distress Screening Final.pdf Supplementary Document	2019-06-20
Distress Screeening SSA final.doc Supporting Statement A	2019-06-20
Att 6a - Westat Continuing IRB Approval DS.pdf Supplementary Document	2019-06-17
Att 6 - Westat Initial IRB Approval DS.pdf Supplementary Document	2019-06-17
Att 5c - FU email to schedule potential interviewees DS.docx Supplementary Document	2019-06-17
Att 5b - Email invitation to potential interviewees DS.docx Supplementary Document	2019-06-17
Att 5a - Int & focus grp respondent info form DS.docx Supplementary Document	2019-06-17
Att 3d - Healthcare facilities IRB info DS.docx Supplementary Document	2019-06-17
Att 3c - FAQs DS.docx Supplementary Document	2019-06-17
Att 3b - Initial recruitment email to study partners DS.docx Supplementary Document	2019-06-17
Att 3a - Initial recruitment email to potential healthcare facilities DS.docx Supplementary Document	2019-06-17
Att 2 60-day FRN DS.pdf Supplementary Document	2019-06-17
Att 1 - Authorizing Legislation DS.doc Supplementary Document	2019-06-17
Distress Screening SSB.docx Supporting Statement B	2019-06-17

IC Document Collections

IC ID	Document Title	Status
236527	Focus Groups Form and Instruction	New
236526	Key Informant Interview Guide and Consent Form and Instruction	New
236525	EHR Data Form and Instruction	New
236524	Healthcare Professionals Survey Instruction	New

ICR Details

OMB Control No: 0920-1270	ICR Reference No: 201906-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19MM
Title: The Centers for Disease Control and Prevention (CDC) Study on Disparities in Distress Screening among Lung and Ovarian Cancer Survivors
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 without change	Conclusion Date: 10/09/2019
	Date Received in OIRA: 07/05/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	12 Months From Approved
Responses	184	0	0
Time Burden (Hours)	512	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to examine the extent to which disparities exist in distress screening and follow-up care among cancer treatment facilities and programs across the country. CDC believes that it is imperative to develop a greater understanding about the types of services for lung and ovarian cancer survivors because they experience high levels of distress and are among those who experience the lowest 5-year survival rates.

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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:
	84 FR 8100	03/06/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 32179	07/05/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Focus Groups	0920-19MM	Focus Group Interview Guide
Healthcare Professionals Survey
EHR Data	0920-19MM	EHR data collection tool
Key Informant Interview Guide and Consent	0920-19MM	Key Informant interview guide

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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	184	0	0	184	0	0
Annual Time Burden (Hours)	512	0	0	512	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 collection

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Annual Cost to Federal Government: $142,077

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.     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: 07/05/2019

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