Supporting Statement

Questionnaire Pre-Testing for the

National Adult Tobacco Survey

Submitted under the Generic Clearance for “Health Marketing”

OMB No. 0920-0798

National Center for Health Marketing

Centers for Disease Control and Prevention

July 23, 2009

Point of Contact

Martha Engstrom, PhD

Office on Smoking and Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Telephone: 770.488.5749

Fax: 770.488.4858

Email: mengstrom@cdc.gov

URGENT (see Justification, paragraph 4)

A. Justification

1. Circumstances Making the Collection of Information Necessary

CDC is currently approved to collect information about the development, implementation, and utility of public health services, products, and communication campaigns (see generic approval entitled “Health Marketing,” OMB No. 0920-0798). Information collection requests related to the development of surveys and informational materials receive expedited review (usually in 10 business days) when submitted to OMB within the generic Health Marketing framework.

This submission requests OMB approval to conduct a pre-test of information collection procedures for the upcoming National Adult Tobacco Survey (NATS), a telephone-based survey of adults to be conducted in 2009-2010 (an Information Collection Request for the NATS is being processed concurrently). The NATS is sponsored by CDC’s Office on Smoking and Health (OSH) which manages the National Tobacco Control Program (NTCP). The NTCP provides funding and technical assistance to state and territorial governments to promote four goals: (1) prevent initiation of tobacco use among young people; (2) eliminate nonsmokers’ exposure to secondhand smoke; (3) promote quitting among adults and young people; and (4) identify and eliminate tobacco-related disparities.

The NATS questionnaire was designed using constructs from CDC’s guidance on Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs. CDC/OSH requests OMB approval to pre-test the NATS questionnaire and data collection procedures prior to initiating data collection for the national survey. The pre-test will involve a total of 350 respondents: 200 for the initial English language questionnaire pre-test, and 150 for the second pre-test including Spanish language questionnaire interviews.

The timing of the pre-test is critical to the success of the national survey. Because Federally sponsored household surveys are restricted during the period of the U.S. Census (March 1 – August 30, 2010), the principal NATS data collection cannot be conducted during the originally scheduled timeframe of Fall 2009 – Fall 2010, and data collection must be compressed into the Fall 2009 – Winter 2010 period. Conducting a pre-test of the NATS questionnaire in August/September 2009 will allow CDC/OSH to identify – and to take corrective action for – any unforeseen problems with the clarity of the questions, the response options, the burden estimate, or other implementation issues that could impede success of the principal NATS data collection.

2. Purpose and Use of Information Collection

The main purposes of the pretest are to confirm that all aspects of CATI programming (e.g., skip patterns) are working correctly and to confirm that the respondent burden corresponds with our estimates of an interview length of 22 minutes on average, including 2 minutes for screening.

Secondary purposes of the pre-test are to provide a larger test than was feasible through cognitive interviews to ensure respondent understanding of questions, instructions, and transitions, so these can potentially be further refined prior to the full-scale data collection. Pre-test interviews will be heavily monitored by ICF Macro project management and Quality Assurance staff, and interviewer feedback on the survey instrument will be collected. In addition, after completion of the questionnaire, respondents will be asked if any of the questions caused them confusion and, if so, how those questions could be reworded to be clearer.

While both pre-tests will allow for revisions to the CATI program, the initial pre-test of 200 interviews will focus on the main questionnaire. The second pre-test of 150 interviews will include instrument revisions made in response to the first pre-test, and collection of Spanish language interviews.

The overall purpose of the NATS is to determine tobacco use prevalence and the factors promoting and impeding tobacco use among adults in a nationally representative sample. In addition, NATS will provide critical evaluation data to support CDC’s National Tobacco Control program.

3. Use of Improved Information Technology and Burden Reduction

Information will be collected by a contractor using computer-assisted telephone interview (CATI) methodology. The pre-test will involve only land-line telephones. There are no options for paper- or web-based surveys. There are no legal barriers to the use of information technology to reduce burden.

4. Efforts to Identify Duplication and Use of Similar Information

The NATS questionnaire is a new data collection instrument. There are no other previous, current, or planned efforts to conduct a comprehensive survey of tobacco use behaviors, exposure to pro- and anti-tobacco influences, and key short-term and intermediate outcome indicators among a national sample of adults based on CDC’s Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs.

5. Impact on Small Businesses or Other Small Entities

Respondents for the NATS pre-test are individuals 18 years of age or older. No small businesses or small entities will be involved.

6. Consequences of Collecting the Information Less Frequently

Lack of pre-testing data could result in failure to identify and clarify confusing questions, thus compromising data quality and potentially increasing burden to respondents.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the guidelines of 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A Federal Register Notice is not required for collecting pre-test information under the generic Health Marketing approval. An announcement of CDC’s intent to conduct the principal NATS data collection was published in the Federal Register on June 6, 2009 (Vol. 74, No. 108, pp. 27144-27145).

9. Explanation of Any Payment or Gift to Respondents

No payment or incentive will be offered.

10. Assurance of Confidentiality Provided to Respondents

This data collection has received IRB approval from the CDC Human Research Protection Office (protocol #200-2002-00575/TBD; expiration: 8/11/2010). Verbal consent will be elicited from respondents.  Before each interview, the interviewer will read the informed consent to each participant. The consent form describes the interview, the types of questions that will be asked on the actual survey, the risks and benefits of participation, and participants’ rights, and it provides information on whom to contact with questions about any aspect of the study. The consent form also indicates that participation is completely voluntary and that participants can refuse to answer any question or discontinue the interview at any time without penalty or loss of benefits. The interviewer will enter a code via the keyboard to signify that the participant was read the informed consent script and agreed to participate.

All interviewers will be required to sign a statement of confidentiality on the date of hire, which will be reinforced at training. Respondents will be told during the initial screener that the information they provide will be maintained in a confidential manner.  In addition, interviewers will be instructed to discontinue a call if they feel someone is listening on another line. 

This study will collect information on tobacco use, environmental smoke exposure, attempts to quit tobacco use, and exposure to forces promoting and impeding tobacco use. Data on tobacco use are generally regarded as being no greater than minimally sensitive. Therefore, the data collection will have little or no effect on the respondent’s privacy. Nevertheless, safeguards will be put in place to ensure that all collected data remain private. Survey data and all identifying information about respondents will be handled in ways that prevent unauthorized access at any point during the study.  To maintain privacy, only a sub-string of the telephone numbers associated with each completed call is included in the analysis dataset, so a respondent's answers cannot be connected to a specific person or telephone number.   If reports or tabular data are submitted, the data will be reviewed to determine if the subject(s) can be identified when small cell counts occur.  If there is the potential for the identification of these subject(s), the data in these cells will be removed.

Pre-testing data will be maintained for one month to enable analysis and to finalize the NATS instrument. Pre-testing data will not be retained for analysis with the principal NATS information collection.

11. Justification for Sensitive Questions

There are a total of 114 out of 157 specific tobacco-related questions on the NATS questionnaire. The items are for the most part, not of a sensitive nature and are commonly found in surveys of health behavior. There are no questions concerning sensitive topics such as illegal drug use, criminal acts, or emotionally charged experiences.

The one question that may be considered sensitive concerns sexual orientation. Research on smoking and reasons for starting smoking have established some links between sexual orientation and propensity to smoke. Published literature on smoking among gay, lesbian, and bisexual individuals consistently finds higher rates of smoking compared to the general population (Ryan et al., 2001), and sexual orientation has been identified with health--related disparities. This question is thus necessary for designing effective interventions for tobacco users.

The NATS includes 14 questions which are demographic in nature, four of which ask about race and ethnicity and may be considered sensitive by a portion of respondents. The demographic questions are necessary for analysis purposes and for compliance with HHS policy.

12. Estimates of Annualized Burden Hours and Costs

We anticipate a time commitment of approximately 22 minutes from consenting respondents: 2 minutes for screening and approximately 20 minutes for the survey. The total estimated burden hours are 137.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
General Public > 18 years of age	Screener (pages 2-18)	613	1	2/60	20
	National Adult Tobacco Survey (pages 19-92)	350	1	20/60	117
	Total				137

There are no costs to respondents other than their time. The Department of Labor estimates the mean of state, local, and private industry earnings as $23/hour. The total estimated cost to respondents, is $3,153.

Estimated Annualized Cost to Respondents

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Average Hourly Wage	Total Cost
General Public > 18 years of age	Screener (pages 2-18)	613	1	2/60	$23	$470
	National Adult Tobacco Survey (pages 19-92)	350	1	20/60	$23	$2,683
	Total					$3,153

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no additional costs to the respondents.

14. Annualized Cost to the Federal Government

Information will be collected by a contractor, Macro International. The cost of the pre-testing activity is included in the costs presented in the ICR for the NATS.

15. Explanation for Program Changes or Adjustments

This is new data collection.

16. Plans for Tabulation and Publication and Project Time Schedule

August 17^th – 23^rd Pre-test initial 200 interviews

August 28^th Deliver English pre-test data set to OSH

Sept. 7^th – 11^th Revisions to CATI program based on pre-test results/data set review, program testing, re-running of skip checks and other testing measures

Sept. 14^th- 16^th Pre-test additional 150 interviews, including Hispanic oversample

Sept. 18^th Deliver 2^nd pre-test data set to OSH

17. Reasons(s) Display of OMB Expiration Date is Inappropriate

Exemption is not being sought.

18. Exceptions to Certification for Paperwork Reduction Act Submission

There are no exceptions to certification.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

1. Respondent Universe and Sampling Methods

Respondents will be adults ages 18 and over. For the initial pre-test of 200 interviews, ICF Macro will draw a list-assisted, random-digit dial sample nationally of households with telephones. ICF Macro will select the sample using an in-house Genesys Sampling System. The sampled numbers are purged for known businesses. The selected telephone numbers will be sent to Genesys to be reverse matched to their listed database. The selected telephone numbers will be grouped into sample replicates of 50 for managing the sample. For the second pre-test, to ensure that we can adequately test the Spanish instrument, ICF Macro will design and select a supplemental sample from a surname list obtained from a commercial vendor (e.g., Genesys or SSI).

2. Procedures for the Collection of Information

Information will be collected by a contractor (Macro International) using computer-assisted telephone interview (CATI) methodology. Respondents will be briefly screened to ensure eligibility.

3. Methods to Maximize Response Rates and Deal with Nonresponse

All procedures normally used to produce response, including call-backs and refusal conversion, will be employed during the pretest. As a result, the pre-test will provide information that will inform the process of estimating response rates.

4. Tests of Procedures or Methods to be Undertaken

Questions were developed through formative research and experience with other tobacco-related data collection activities. The question on sexual orientation was tested previously in cognitive interviews in preparation of questionnaires for other OMB-approved studies (Hispanic/Latino ATS OMB No. 0920-0726; expiration: 8/31/2008; and the American Indian/Alaskan Native ATS OMB No. 0920-0671; expiration: 1/31/2008). Cognitive interviews revealed there was no issue of embarrassment in answering. Interviewers will be trained to ask the sexual orientation question in a neutral manner. If the interviewer senses any discomfort or reluctance to answer the question, the interviewer will be instructed to remind the respondent that he/she may choose to not answer the question.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or

Analyzing Data

This study does not employ a statistical design.

Within the agency, the following individual will be responsible for receiving and approving contract deliverables and will have primary responsibility for data analysis:

Martha C. Engstrom, Ph.D.
Centers for Disease Control and Prevention (CDC)
National Center for Chronic Disease Prevention and Health Promotion
Office on Smoking and Health
4770 Buford Highway Mailstop K-50
Atlanta, Georgia 30341
(770) 488-5749
mengstrom@cdc.gov

The representative of the contractor responsible for conducting the planned data collection is:

Naomi Freedner, M.P.H.

Macro International Inc. (ICF Macro)

26 College Street

Burlington, VT 05401

(802) 863-9600

Naomi.L.Freedner@macrointernational.com