Exploratory Research with People Living with Lung Cancer

Forms and Documents

Document Name	Status
Form 5 Indepth Inverview Guide and Consent form Form and Instruction	New
Form 4 Screening Form Form	New
Form 1 Clinic Staff Instructions: Contact Information and the Consent to be Contacted Form and Instruction	New
Att 9 Informed Consent Form 06.17.09.doc Supplementary Document	2009-06-17
Att 8 Screening Form 06.17.09.doc Supplementary Document	2009-06-17
Att 7 Scott and White Consent Form Revised 06.17.09.doc Supplementary Document	2009-06-17
Att 5 Instructions for Clinic Staff Revised 06.17.09.doc Supplementary Document	2009-06-17
Att 4 Recruitment Flyer 06.17.09.doc Supplementary Document	2009-06-17
SS Part B Revised 03.12.09.doc Supporting Statement B	2009-03-20
Att 2B Summary of Public Comments.doc Supplementary Document	2009-03-20
Att 2A 60 day Federal Register Notice.doc Supplementary Document	2009-03-20
Att 1 Authorizing Legislation.doc Supplementary Document	2009-03-20
Att 4 Recruitment Flyer.doc Supplementary Document	2009-03-20
SS Part A Revised 06.17.09.doc Supporting Statement A	2009-06-17

IC Document Collections

IC ID	Document Title	Status
188701	Indepth Inverview Guide and Consent form Form and Instruction	New
188700	Screening Form Form	New
188699	Clinic Staff Instructions: Contact Information and the Consent to be Contacted Form and Instruction	New

ICR Details

OMB Control No: 0920-0813	ICR Reference No: 200904-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Exploratory Research with People Living with Lung Cancer
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: 06/22/2009
	Date Received in OIRA: 04/06/2009
Terms of Clearance: Approved consistent with modified documents uploaded on 6/17/2009.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	12 Months From Approved
Responses	181	0	0
Time Burden (Hours)	50	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Lung cancer is the most common cancer and the leading cause of cancer-related mortality in the world. Each year, over 150,000 Americans are diagnosed with lung cancer and a similar number die from the disease. CDC proposes to conduct a new information collection to address gaps in knowledge about the experiences of people living with lung cancer. Information will be collected from lung cancer patients concerning their experiences related to their diagnosis, potential stigma and victim blaming, and opportunities for counseling and support services. The study is formative and may be used to improve education and screening interventions, and to inform future research activities.

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Authorizing Statute(s): US Code: 42 USC 301.241 Name of Law: Public Health Service Act - Research and Investigation
  

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:
	73 FR 45224	08/04/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 12872	03/25/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Clinic Staff Instructions: Contact Information and the Consent to be Contacted	1, 3, 2	Instructions for Clinic Staff & Consent form ,   Scott and White Consent Form ,   Contact Information and Consent Form
Screening Form	4	Screening Form
Indepth Inverview Guide and Consent form	5, 6	Informed Consent ,   In-Depth Interview Guide and Form

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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	181	0	0	181	0	0
Annual Time Burden (Hours)	50	0	0	50	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 information collection request to address the knowledge gaps about the experiences of people living with lung cancer. Information will be collected from lung cancer patients concerning their experiences related to their diagnosis, potential stigma and victim blaming, and opportunities for counseling and support services. The study is formative and may be used to improve education and screening interventions, and to inform future research activities.

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Annual Cost to Federal Government: $108,934

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? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 04/06/2009

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