Human Smoking Behavior Study

Forms and Documents

Document Name	Status
mar 2007 omb questions and responses Smoking (2).doc Supplementary Document	2007-03-16
mar 14 2007 requested revisions to supporting stmt.doc Supplementary Document	2007-03-16
Supporting Statement B 11-22-2006.doc Supporting Statement B	2007-03-16
091506 Memorandum2.doc Supplementary Document	2006-11-09
Attachment I Table of Biomarkers.pdf Supplementary Document	2006-11-09
Attachment H Recruitment Advertisement Flyer.doc Supplementary Document	2006-11-08
Attachment FnFederal Register Comments.doc Supplementary Document	2006-11-08
Attachment G IRB Approval letter.doc Supplementary Document	2006-11-08
Attachment D Informed Consent .doc Supplementary Document	2006-11-08
Supporting Statement A 11-22-2006.doc Supporting Statement A	2007-03-16

IC Document Collections

IC ID	Document Title	Status
46217	Human Smoking Behavior Study Other-Other	New
46216	Human Smoking Behavior Study Instruction	New

ICR Details

OMB Control No: 0920-0736	ICR Reference No: 200611-0920-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Human Smoking Behavior Study
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: 03/22/2007
	Date Received in OIRA: 11/29/2006
Terms of Clearance: Approved consistent with the following terms clearance: approved consistent with CDC revisions to the proposed study as outlined in attached response memos, CDC will revise the consent form as agreed and upon receiving IRB approval CDC will notify OMB that the changes have been accepted. In the event that any of the changes discussed are rejected by the IRB, CDC will consult with OMB prior to beginning the study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved
Responses	860	0	0
Time Burden (Hours)	402	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study will determine typical smoking patterns across a range of cigarette categories, and how different cigarette categories yield variation in markers of exposure to smoke constituents. Approximately 360 established smokers of different races/ethnicities will be recruited. Information gained will be used to better understand how tobacco causes disease and to improve smoking machine protocols for researchers.

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Authorizing Statute(s): PL: Pub.L. 104 - 134 101(d) Name of Law: Public Health and Welfare
   PL: Pub.L. 104 - 140 1(a) Name of Law: Public Health and Welfare
  

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:
	71 FR 6878	02/09/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 65526	11/08/2006
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Human Smoking Behavior Study
Human Smoking Behavior Study

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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	860	0	0	860	0	0
Annual Time Burden (Hours)	402	0	0	402	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: No changes are being made, this is a new collection.

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Annual Cost to Federal Government: $627,982

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]? 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)? Uncollected

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: 11/14/2006

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