Human Smoking Behavior Study

Forms and Documents

Document Name	Status
Form No number Visit 1 screener Form	Modified
Form No number CATI screener Form	Modified
Form No number Laboratory visit Form	New
Form No number Smoking diary Form	New
SS-B 08 17 2010.doc Supporting Statement B	2010-08-23
Attachment J. References.doc Supplementary Document	2010-08-23
Attachment I. IRB Approval.DOC Supplementary Document	2010-08-23
Attachment F. Advertisements.pdf Supplementary Document	2010-08-23
Attachment E-2. Informed Consent.doc Supplementary Document	2010-08-23
Attachment C. Table of Biomarkers.doc Supplementary Document	2010-08-23
Attachment B. Federal Register Notice.pdf Supplementary Document	2010-08-23
Attachment A-2. PHSA.doc Supplementary Document	2010-08-23
Attachment A-1. FCLAA.docx Supplementary Document	2010-08-23
Attachment G-2. Lab Visit Instructions.docx Supplementary Document	2010-08-23
SS-A 08 17 2010.doc Supporting Statement A	2010-09-30

IC Document Collections

IC ID	Document Title	Status
46217	Visit 1 screener Form	Modified
46216	CATI screener Form	Modified
194764	Laboratory visit Form	New
194763	Smoking diary Form	New

ICR Details

OMB Control No: 0920-0736	ICR Reference No: 201009-0920-006
Status: Historical Active	Previous ICR Reference No: 200908-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Human Smoking Behavior Study
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/20/2010
	Date Received in OIRA: 09/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2012	24 Months From Approved
Responses	403	0	0
Time Burden (Hours)	151	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests OMB approval for two years in order to complete a research study designed to elucidate patterns of human smoking behavior, quantify biomarkers of exposure to smoke toxins under conditions of actual use, and assess how smoking behavior modifies the relationship between cigarette yield category, biomarkers of exposure, and measures of cardiovascular reactivity.

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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:
	75 FR 9901	03/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 53311	08/31/2010
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
Laboratory visit	No number	Laboratory visit
CATI screener	No number	CATI screener
Visit 1 screener	No number	Visit 1 screener
Smoking diary	No number	Smoking diary

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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	403	0	0	403	0	0
Annual Time Burden (Hours)	151	0	0	151	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 reinstatement with change.

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Annual Cost to Federal Government: $723,517

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: 09/30/2010

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