NYTS Pilot SupSta A

2017 NATIONAL YOUTH TOBACCO SURVEY Computer Based Pilot Survey

OMB No. 0920-16AWN

SUPPORTING STATEMENT: PART A

ICRO’s Desk Officer Review

December 1, 2016

Submitted by:

Ahmed Jamal, MBBS, MPH

Centers for Disease Control and Prevention

Office on Smoking and Health

Epidemiology Branch

4770 Buford Highway NE, MS-F 79

Atlanta, GA 30341

Phone: 770-488-5077

E-mail: AJamal@cdc.gov

Centers for Disease Control and Prevention

Department of Health and Human Services

TABLE OF CONTENTS

A. JUSTIFICATION

A.1. Circumstances Making the Collection of Information Necessary

A.2. Purpose and Use of Information Collection

A.3. Use of Improved Information Technology and Burden Reduction

A.4. Efforts to Identify Duplication and Use of Similar Information

A.5. Impact on Small Businesses or Other Small Entities

A.6. Consequences of Collecting the Information Less Frequently

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

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

A.9. Explanation of Any Payment or Gift to Respondents

A.10. Assurance of Confidentiality Provided to Respondents

A.11. Justification for Sensitive Questions

A.12. Estimates of Annualized Burden Hours and Costs

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

A.14. Annualized Cost to the Government

A.15. Explanation for Program Changes or Adjustments

A.16. Plans for Tabulation and Publication and Project Time Schedule

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

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

REFERENCES

LIST OF ATTACHMENTS

1. Authorizing Legislation

B1. 60-Day Federal Register Notice

B2. Public Comment on the 60-Day Federal Register Notice and CDC Response

C. State Tobacco Control Reports that Cite National Youth Tobacco Survey Data

D. Publications from Prior Cycles of the National Youth Tobacco Survey

E1. State-level Recruitment Script for the National Youth Tobacco Survey

E2. State-level Recruitment Script for the National Youth Tobacco Survey Supplemental Document – State Letter of Invitation

F1. District-level Recruitment Script for the National Youth Tobacco Survey

F2. District-level Recruitment Script for the National Youth Tobacco Survey Supplemental Document – District Letter of Invitation

G1. School-level Recruitment Script for the National Youth Tobacco Survey

G2. School-level Recruitment Script for the National Youth Tobacco Survey Supplemental Documents – School Letter of Invitation and NYTS Fact Sheet for Schools

G3. School-level Recruitment Script for the National Youth Tobacco Survey Supplemental Documents – Letter to Agreeing Schools

H1. Data Collection Checklist for the National Youth Tobacco Survey

H2. Data Collection Checklist for the National Youth Tobacco Survey Supplemental Documents – Letter to Teachers in Participating Schools

I1. National Youth Tobacco Survey Questionnaire

I2. National Youth Tobacco Survey Questionnaire Supplemental Documents – Parental Permission Form Distribution Script

I3. National Youth Tobacco Survey Questionnaire Supplemental Documents – Parental Permission Form and Fact Sheet (English Version)

I4. National Youth Tobacco Survey Questionnaire Supplemental Documents – Parental Permission Form and Fact Sheet (Spanish Version)

I5. National Youth Tobacco Survey Questionnaire Supplemental Documents – Parental Permission Form Reminder Notice (English Version)

I6. National Youth Tobacco Survey Questionnaire Supplemental Documents – Parental Permission Form Reminder Notice (Spanish Version)

I7. National Youth Tobacco Survey Questionnaire Supplemental Documents – Questionnaire Administration Script

I8. Example: Instrument Testing Activity

J. IRB Approval Letter

K. Sample Table Shells

L. Detailed Sampling and Weighting Plan

LIST OF TABLES

Table A.12a – Estimated Annualized Burden Hours

Table A.12b – Annualized Estimated Cost to Respondents

Table A.14a – Annualized Study Cost

Table B.1a – Distribution of Schools by Urban Status and School Type

Table B.3a – Major Means of Quality Control

• Goal of the study: The NYTS electronic pilot is designed to assess the overall distribution and determinants of tobacco use behaviors among youth enrolled in grades 6-12 compared to the paper and pencil (PAPI) mode.

• Intended use of the resulting data: The purpose of the 2017 NYTS electronic pilot is to evaluate the effectiveness and efficiency of using of an electronic mode of data collection for the survey. The objective is to assess the efficiency and reliability of electronic survey data collection about national tobacco usage among youth in grades 6-12.

• Methods to be used to collect: The NYTS pilot evaluation will use the same repeat cross-sectional design as the paper and pencil NYTS. The information collection proposed in this request is similar to previous NYTS OMB-approved sampling strategy and recruitment methods (OMB No. 0920-0621; exp. 1/31/2018).

• The subpopulation to be studied: NYTS pilot is proposed to be conducted among a nationally representative sample of students in approximately 64 schools (both public and private) enrolled in grades 6-12.

• How data will be analyzed: Data will be compared to the paper-based survey results. The primary purpose of the NYTS electronic pilot evaluation is to assess the use of an electronic device to administer the survey.

OVERVIEW

CDC requests OMB approval for one year to conduct a pilot evaluation of an electronic mode of administration of the National Youth Tobacco Survey (NYTS). This Pilot is an electronic-based version of the NYTS previously administered via paper and pencil (PAPI) by CDC in 2004, 2006, 2009, and on an annual basis for years 2011-2016. The most recent OMB approval was for NYTS information collection in 2015, 2016, and 2017 (“2015 - 2017 National Youth Tobacco Survey (NYTS),” OMB no. 0920-0621, exp. 1/31/2018).

The need to test an electronic version of the NYTS has been prompted by the introduction of technology in survey administration, the adaptability of technology by students, and the potential gain in efficiency and effectiveness of data collection, analyses and dissemination of findings along with a potential cost-savings by using modern technology. The pilot evaluation will be used to better understand how an electronic mode could be used in the future to administer surveys to students. The NYTS pilot evaluation will use the same repeat cross-sectional design as the paper and pencil NYTS to develop national estimates of tobacco use behaviors and exposure to pro- and anti-tobacco influences among students enrolled in grades 6-12. The estimated burden per response will be 35 minutes.

A. JUSTIFICATION

A.1 CIRCUMSTANCES MAKING THE COLLECTION OF INFORMATION NECESSARY

This statement supports a request to obtain approval for a new information collection request to conduct the school-based National Youth Tobacco Survey (NYTS) Pilot for one year. The NYTS electronic pilot is designed to assess overall distribution and determinants of tobacco use behaviors among youth enrolled in grades 6-12 compared to the paper and pencil National Youth Tobacco Survey. The justification for the NYTS electronic pilot is based on five factors of comparison with the paper NYTS: (1) assessing respondent burden; 2) understanding reliability and efficiencies of electronic mode data collection; (3) assessing reliability and validity of survey results obtained from electronic data; (4) assessing cost-effectiveness of electronic administration; and (5) measuring the length of time between data collection and dissemination of findings.

CDC is responsible for administering the NYTS. Data previously collected from NYTS have been used to inform and evaluate the National Comprehensive Tobacco Control Program; inform progress towards achieving Healthy People 2020 objectives related to tobacco and youth; provide data to inform the Department of Health and Human Service’s Tobacco Control Strategic Action Plan, and provide national and state-level benchmark data for Youth Tobacco Surveys and for international comparison through the Global Youth Tobacco Survey. CDC is also responsible for leading and coordinating national strategic efforts aimed at preventing tobacco initiation, promoting tobacco cessation, protecting nonsmokers from secondhand smoke, and eliminating tobacco-related health disparities. A comprehensive tobacco control program must have surveillance and evaluation systems to track and document a wide range of short-term, intermediate, and long-term intervention outcomes in the population, the data from which can inform public health policy efforts, as well as demonstrate programmatic and fiscal accountability (CDC, 2014a). CDC wishes to understand the impact, validity, and efficiencies of switching to an electronic mode of data collection for the NYTS.

The objective of this survey is to assess the efficiency and reliability of electronic survey data collection about national tobacco usage among youth in grades 6-12. By using a computer-assisted self-interview approach, the survey can incorporate automated collection techniques, conditional ‘skip logic’ routing, and adaptive survey design in an efficient and reliable mode which minimizes respondent burden. In addition, we aim to understand if this pilot meets expectations of students for survey data collection given the increased use of technology in the classroom. Participating students will complete the survey in person in a classroom setting. Findings from the electronic data will be compared to the paper-based survey results.

The NYTS pilot will provide increased understanding of the effects of using a computer-assisted self-interview to measure knowledge, attitudes, perceptions and behaviors related to multiple tobacco products (cigarettes, cigars, etc.). The pilot electronic administration is essential to the future design, implementation, and evaluation of comprehensive youth tobacco prevention and control programs by a variety of federal, state, and local stakeholders.

CDC requests OMB approval to conduct the NYTS electronic pilot in 2017. The NYTS is conducted in a school-based setting. Respondents are students in grades 6-12.

A.2 PURPOSE AND USE OF INFORMATION COLLECTION

The primary purpose of the NYTS electronic pilot evaluation is to assess the use of an electronic device to administer the survey.

The specific aims of the electronic survey are to:

1. Assess respondent burden of electronic administration compared to PAPI mode.

2. Compare the administration of the electronic survey mode to the PAPI mode to compare reliability and efficiencies.

3. Understand overall validity in results of using an electronic mode.

4. Better understand perceptions of students’ confidentiality when using an electronic mode of collection.

5. Test for efficiencies and challenges to efficiencies in cost, data validation, and turnaround time in the dissemination of results.
   
   

CDC’s Office on Smoking and Health will use the results of the NYTS electronic pilot to test the practical considerations of administering the NYTS via an electronic device. Results will also be used to help guide evaluate the impact of automated collection techniques and electronic survey administration on response burden.

There is currently very little up to date information available on validity, and efficiencies in using an electronic device mode of data collection in schools. Several government agencies will be interested in the results of the Pilot survey as they will help inform some of their own thinking around data collection in schools.

The NYTS electronic survey results are of interest not only to CDC, but also to other Federal agencies and departments.

A.3 USE OF IMPROVED INFORMATION TECHNOLOGY AND BURDEN REDUCTION

To reduce burden, the NYTS methodology is transformed from the conventional paper-based survey to a sophisticated, state-of-the-art computer-based survey, which enables students to submit survey responses using hand-held computer tablets. By converting to a computer-based data collection methodology, the survey will incorporate conditional ‘skip logic’ routing and adaptive survey design in a user-friendly and intuitive interface that makes data collection as simple and efficient as possible.

A.4 EFFORTS TO IDENTIFY DUPLICATION AND USE OF SIMILAR INFORMATION

CDC conducts ongoing searches of all major educational and health-related electronic databases, reviews related literature, consults with key outside partners and other experts, and maintains continuing communications with Federal agencies with related missions. These efforts have identified no 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 nationally representative sample of students in grades 6 through 12. The NYTS is inherently distinct from other existing population-level surveys that are conducted with different areas of emphasis and/or with different populations. The Pilot is further distinct in that it is the only computer based Pilot of the NYTS being conducted.

Other surveys that ask tobacco-related questions include the Youth Risk Behavior Survey (YRBS) (OMB No. 0920-0493, exp. 9/30/2015, and the NSDUH, OMB No. 0930-0110). However, the YRBS is not duplicative of the NYTS electronic pilot. Unlike the YRBS, the NYTS electronic pilot gathers data among high school (grades 9^th to 12^th) students, as well as among middle school (grades 6^th to 8^th) students; NYTS is currently the only source of such extensive data on tobacco use among both middle and high school students in the United States. In addition, all other national surveys (YRBS, National Survey on Drug Use and Health (NSDUH), and Monitoring The Future (MTF)) are multi-risk factor surveys that can ask only a limited number of questions about specific risk behaviors. Tobacco use is related to a wide spectrum of other health behaviors and health outcomes, and thus, is a critical measure to include in surveys of many topics among youth and adults. However, the tobacco-related questions in those multi-purpose surveys cannot meet the needs specific to the evaluation of tobacco prevention and control activities at the national level.

Smaller-area surveys help to inform programmatic activities at state and local levels but are not designed to produce national estimates.  CDC assists states with the implementation of their own state youth tobacco surveys (YTS), however, substantial variation across jurisdictions in sampling techniques, questions, and survey administration procedures prohibit the calculation of national estimates from state-level results. Therefore, while smaller area surveys are essential tools for informing programmatic activities at the state level, they are insufficient to meet national data needs.

Surveys for youth and adults include differing questions and survey modes by design. For NYTS electronic pilot, the survey is administered at schools because that provides the most secure setting for youth and it is also where most youth are during weekdays. This mode would not be suitable for adults. Similarly, some tobacco-use questions asked of youth, who are legally prohibited from purchasing tobacco and for whom tobacco use may be a recently acquired behavior, would not be appropriate for adults. 

In the early 1990s the rapid rise in youth prevalence of tobacco use demonstrated the need for frequent assessments in order to identify such patterns in a timely manner in order to mitigate the damage. In addition, many changes are occurring in the tobacco control and tobacco product landscape, making it important to closely monitor their impacts on youth. In 2012, OMB approved the administration of the NYTS on an annual basis, and CDC and FDA began collaborating on ways to use the NYTS to help FDA inform its regulatory authority. Typically, NYTS instrument content in odd years will reflect an emphasis on information needed to inform CDC’s non-regulatory public health approaches, and NYTS instrument content in even years will reflect an emphasis on information needed to inform FDA’s regulatory activities. Thus, the survey is specifically being designed to avoid duplication while meeting the needs of both agencies. Beginning in 2012, questions were added to the survey specifically related to FDA’s regulatory authority, including awareness of tobacco product health warnings, perceptions about the harms of tobacco products, use of flavored tobacco products, symptoms of tobacco dependence, and ease of minors’ access to tobacco.

For the 2017 NYTS questionnaire, the CDC and FDA established a working group to obtain guidance and suggestions for new items on the questionnaire that would help facilitate the measurement of key data needed to address the missions of both agencies. Working group members include:

	2017 NYTS Consultants: Office on Smoking and Health, Centers for Disease Control and Prevention 4770 Buford Highway NE, Atlanta GA 30321
	Linda J. Neff, Ph.D., M.S.P.H. Epidemiology Branch Chief Phone: 770-488-8647 E-mail: LNeff@cdc.gov	David Homa, Ph.D., M.P.H. Senior Science Advisor for the Epidemiology Branch Phone: 770-488-3626 E-mail: DHoma@cdc.gov
2017 NYTS Consultants: Center for Tobacco Products Food and Drug Administration 10903 New Hampshire Ave, Silver Spring, MD 20993
Benjamin Apelberg, Ph.D., M.H.S. Epidemiologist Phone: 301-796-8869 E-mail: Benjamin.Apelberg@fda.hhs.gov		Conrad Choiniere, Ph.D. Social Scientist Phone: 301-796-9228 E-mail: Conrad.Choiniere@fda.hhs.gov
Corinne Husten, M.D., M.P.H. Senior Medical Advisor Phone: 301-796-9201 E-mail: Corinne.Husten@fda.hhs.gov

In addition to CDC-FDA collaboration specific to the NYTS, enhanced review procedures were instituted in 2013 to promote overall efficiency and quality in federally-sponsored data collection relating to tobacco use and control. These efforts are coordinated through the HHS/Assistant Secretary for Planning and Evaluation (ASPE). An inter-agency workgroup was established under the HHS Data Council with representatives from HHS OPDIVS and programs collecting tobacco related data. The role of the group is to build infrastructure and connections to facilitate coordination and communication during the developmental stage of survey design to reduce duplication, improve response rates, reduce respondent burden, and promote standardization of estimates, where feasible. Representatives of the inter-agency workgroup have been consulted in the development of this ICR. Additional federal agencies consulted through this process include NCHS, NIH/NCI, NIH/NIDA, and SAMSHA.

The NYTS is the sole national comprehensive youth tobacco survey specifically designed to monitor and evaluate key short-term (knowledge and attitudes), intermediate (intentions), and long-term (behaviors) outcome indicators of comprehensive tobacco control programs and policies among a nationally representative sample of students in grades 6-12.

HHS/ASPE has approved submission of this Revision ICR for the NYTS.

A.5 IMPACT ON SMALL BUSINESSES OR OTHER SMALL ENTITIES

This data collection will not involve small businesses

A.6 CONSEQUENCES OF COLLECTING THE INFORMATION LESS FREQUENTLY

The Pilot version of the NYTS is only planned for one year. It is necessary to conduct the survey in the same year a PAPI NYTS will be conducted. This will allow for the greatest comparison in results.

A.7 SPECIAL CIRCUMSTANCES RELATING TO THE GUIDELINE OF 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

A.8 COMMENTS IN RESPONSE TO THE FEDERAL REGISTER NOTICE AND EFFORTS TO CONSULT OUTSIDE THE AGENCY

A 60-day Federal Register Notice was published in the Federal Register on August 10, 2016 vol. 81, No. 154, pp. 52869-52870 (See Attachment B). CDC did not receive public comments related to this notice.

Consultations on the design, instrumentation, products, and statistical aspects of the NYTS have occurred at critical junctures during its original design and have continued since it originally received OMB clearance. The purposes of such consultations were to ensure the technical soundness and user relevance of survey results; to verify the importance, relevance, and accessibility of the information sought in the survey; to assess the clarity of instructions; and to minimize respondent burden.

Historically, the state YTS began as a questionnaire developed by and for a small group of state health departments for use in evaluating their tobacco prevention and control program expansions, funded largely by the Master Settlement Agreement. To facilitate state efforts to design, implement, and evaluate their tobacco use prevention and control programs, CDC provided technical assistance to states to enhance the relevance and decrease the respondent burden of the core YTS questionnaire. Thus, periodically, CDC met with representatives from a growing number of states to review their perceptions of the utility of data produced by the YTS, identify and remove redundancies, and identify the most relevant indicators. The core state YTS questionnaire in the summer of 1999 became the core for the first NYTS conducted in the fall of 1999. In February, 2005, CDC met with state and U.S. territory representatives to again solicit stakeholder input on the core YTS instrument.

Although Legacy was responsible for the design, instrumentation, education products, and statistical aspects of the first three cycles of NYTS, Legacy actively consulted with CDC and other partners during each survey cycle. The purpose of these consultations was to ensure the technical soundness; to verify the importance, relevance, and accessibility of the information sought in the survey; to assess the clarity of instructions; and to minimize respondent burden.

The NYTS explicitly drew on a long tradition of consultations that occurred to support other school-based data collections including the lessons derived especially to: (1) develop and implement a sampling plan that efficiently oversamples racial and ethnic minority groups; (2) optimize institutional receptiveness toward the survey and (3) effectively field an anonymous classroom-based survey that can be understood readily by respondents. Consultations were conducted in August 2015 with:

• Bill Ward, Senior Research Scientist Assessments Division: National Assessment Branch, National Center for Education Statistics; William.Ward@ed.gov

• Roberta Woods, Assessment Division Webmaster Assessments Division Administrative Support Services Branch, National Center for Education Statistics: Roberta.Woods@ed.gov

A.9 EXPLANATION OF ANY PAYMENT OR GIFT TO RESPONDENTS

Schools will be given $500 in appreciation for their participation in NYTS electronic pilot. This is the same amount as the NYTS paper version for 2017. No payments will be offered or made to student respondents. OMB first suggested that CDC offer school incentives on school-based surveys as a means of improving school response rates and, thereby, improving the generalizability of results. Increasingly in recent years, school-based data collections, most of which do not fall under OMB review, have offered financial incentives to increase or maintain school participation rates. CDC believes that offering school incentives helps maintain, or slightly increase, school participation rates despite the growing number of competing, non-instructional demands placed on schools, including standardized testing.

A.10 ASSURANCE OF CONFIDENTIALITY PROVIDED TO RESPONDENTS

During recruitment, districts and schools will be informed that anonymity will be maintained throughout data collection, that all data will be safeguarded closely, and that no institutional or individual identifiers will be used in study reports. Anonymity will be promised to students and their parents on the parental permission forms. Additionally, at the start of the survey administration sessions, professionally trained NYTS electronic pilot data collectors will remind students that their responses will be captured anonymously (Questionnaire Administration Script, Attachment I7). At the conclusion of the survey administration session, students will be instructed to hand their tablet to the data collector. The students’ data will immediately be uploaded to the cloud database and erased from the tablet.

This data collection has received IRB approval from the CDC Human Research Protection Office. This approval is noted on the parental permission forms. The current NYTS IRB Approval Letter is in Attachment J.

Privacy Impact Assessment Information

The NYTS electronic pilot will select a representative sample that will support national estimates by grade, public/private school type, and size of school for students enrolled in grades 6-12. The design will further support separate estimates of the prevalence rates of tobacco use among students by school level (middle and high school) type, grade, and size. The procedures for stratification and sample selection are consistency with those from previous cycles of NYTS.

The PAPI sample design vendor will impose a school size threshold as an additional criterion for eligibility. By removing the frame those schools with an aggregate enrollment of less than 25 students across eligible grades, we can improve efficiency and safeguard privacy.

The NYTS electronic pilot takes about 35 minutes to complete. No personal identifiable information is collected in the survey (e.g., student name, class, school, etc.).

On the day of the survey, the data collector will bring all materials needed to conduct the survey. The data collector will work with the respective classroom teacher to determine which students have completed the necessary parental permission form process (using the Data Collection Checklist), and consequently are eligible to take the survey.

After the survey is completed, students will be instructed to return the tablet to the data collector. The data will be immediately uploaded to the cloud database and deleted from the tablet. As the NYTS electronic pilot administration is completed in each selected class, the classroom-specific tablet will be stored in a school-specific box labeled with a school identification number (for weighting purposes only). Sealed school boxes will be transmitted by the NYTS electronic pilot trained data collector to the data collection contractor’s survey processing center.

The 2017 NYTS electronic pilot will be a web based questionnaire delivered on a tablet consisting of 88 questions on a variety of tobacco related topics (Attachment I1). The questions include prevalence of tobacco product use, knowledge and attitudes, media and advertising, exposure to secondhand smoke, minors’ access and enforcement, school curriculum, and cessation.

Students who have obtained parental permission to participate, and are in classrooms selected to participate, will be asked to report about their tobacco use behaviors and behavioral determinants on the tablet.

All selected schools, students, and their parents will be informed that anonymity will be maintained throughout data collection, that all data will be safeguarded closely, and that no institutional or individual identifiers will be used in study reports. Anonymity will be promised to students and their parents on parental permission forms. Students will be reminded that their responses are anonymous at the start of the survey administration session by a professionally trained NYTS electronic pilot data collector.

All contractor staff involved with the project are required to sign a non-disclosure, intellectual property, non-competition and non-solicitation agreement which is a statement of personal commitment to safeguard data obtained.

Data collected from school administrators during recruitment is information that is already available in the public domain; school administrators will not provide personal information. The data collected on the NYTS electronic pilot are not identifiable.

As a means to monitor the parental permission form process and to ensure surveys are completed only by students for whom permission has been obtained, teachers are asked to enter student names on the Data Collection Checklist (similar to a class roll) (Appendix H1). Teachers can substitute any other information in place of student names (such as student ID numbers or letters) on the Data Collection Checklist as long as it will allow them to individually determine which students received parental permission to participate. This information will be conveyed to the data collector on the survey administration day.

The Data Collection Checklist is an optional tool to assist in managing the parental permission and student assent process. It will be destroyed at the end of the study. No individually identifiable information is collected on the NYTS electronic pilot survey (e.g., student name, class, school, etc.), therefore there is no way to connect students’ names to their response data.

Participation in the NYTS electronic pilot should pose little or no effect on the respondent’s privacy.

No individually identifiable information is collected on the NYTS electronic pilot survey (e.g., student name, class, school, etc.), therefore there is no way to connect students’ names to their response data.

For the NYTS electronic pilot, participation is voluntary and respondents will be assured that there is no penalty if they decide not to respond, either to the information collection as a whole or to any particular question.

Although teachers are asked to record student names or another identifier on the Data Collection Checklist (Attachment H1), this information is only used to manage the parental permission and student assent process. Consent to record and provide this information to the CDC or data collection contractor will not be sought. The Data Collection Checklist will be destroyed at the end of the study.

At each school, local procedures for sending home parental permission forms will be followed. Schools will be asked to ensure permission forms are distributed at least 7 days before the survey administration. Teachers track the return of parental permission forms on the Data Collection Checklist to ensure that only students with parental permission participate. A waiver of written student assent was obtained for the participation of children because this research presents no more than minimal risk to subjects, parental permission is required for participation, the waiver will not adversely affect the rights and welfare of the students because they are free to decline to take part, and it is thought that some students may perceive they are not anonymous if they are required to provide stated assent and sign a consent/assent document. Students are told “Participating in this survey is voluntary and your grade in this class will not be affected, whether or not you answer the questions.” Completion of the survey implies student assent.

CDC’s authorized data collection contractor has several security procedures in place to safeguard data. Data that are collected at school remain under the exclusive control of the contractor’s field staff until they are shipped to the contractor’s survey processing center. School personnel are not responsible for collecting and storing any data. The tablets will be stored in a locked file room (within a secured facility), accessible only to staff directly involved in the project. All electronic data will be stored on secured servers and will be accessible only to staff directly involved in the project.

Staff in the CDC Information Collection Review Office have reviewed this application and have determined that the Privacy Act does not apply. No identifying information will be retained in the data record that would enable an individual survey to be tracked back to a particular student.

A.11 JUSTIFICATION FOR SENSITIVE QUESTIONS

Seventy-four of the 88 questions on the NYTS electronic pilot are specific to tobacco-related issues (Attachment I1). Those pertaining to actual tobacco use, especially when asked of underage children, may be considered sensitive by some parents, students, or the school community. However, because getting accurate information on this topic is critical, the NYTS electronic pilot questionnaire must contain these sensitive questions. During the past 25 years, one of the primary responsibilities of CDC has been to monitor priority risk behaviors among youth. To monitor such behaviors, CDC must ask youth about them. Students are told in the instructions to the NYTS electronic pilot (Attachment I7) that “In order to help develop better education programs, educators and health officials must collect comprehensive data on the attitudes, knowledge, and behaviors of middle and high school students (grades 6‑12) with respect to tobacco, and on other influences that might make a youth susceptible to tobacco use in the future.” Students also are instructed to read the front cover of the questionnaire booklet which states, “This survey is about tobacco. We would like to know about you and the things you do that may affect your health. Your answers will be used for programs for young people like yourself.”

The remaining seven questions are demographic factors, two of which ask about race and ethnicity, and two of which are mandatory questions from Department of Health and Human Services Office on Minority Health. OMB considers questions about race and ethnicity to be sensitive. On October 30, 1997, the Office of Management and Budget (OMB) published "Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity" (Federal Register, 62 FR 58781 - 58790). The 1997 standards reflect a change in data collection policy, making it possible for Federal agencies to collect information that reflects the increasing diversity of the U.S. population stemming from growth in interracial marriages and immigration. Under this policy, federal agencies are required to offer respondents the option of selecting one or more race responses from a list of five designated racial categories. Additionally, the standards provide for the collection of data on whether or not a person is of "Hispanic or Latino" culture or origin. Such standards also foster comparability across data collections carried out by various agencies. The race and ethnicity questions in the NYTS electronic pilot follow all guidelines for the development of data collection questions, formats, and associated procedures to implement the 1997 standards.

The questions were developed in close cooperation with representatives from school systems across the nation and are presented in a straightforward and sensitive manner. Parental permission to participate in the NYTS electronic pilot will be obtained.

A.12 ESTIMATES OF ANNUALIZED BURDEN HOURS AND COSTS

Federal tobacco control and surveillance activities must adapt to a dynamic product environment. From time to time, CDC may modify instrument content to reflect changes in the federal government’s need for information to inform public health and regulatory activities. These modifications will be submitted to OMB through the Change Request mechanism.

Before requesting OMB approval of changes to the NYTS electronic pilot questionnaire, CDC may also conduct (i) cognitive testing of new questions, (ii) cognitive testing of proposed changes in the wording of, or response options associated with individual questions, and/or (iii) pre-testing of the NYTS electronic pilot as a whole, to ensure that burden per response remains compatible with administration in one class period. Detailed descriptions of these information collections will also be submitted to OMB under the Change Request mechanism.

The estimated burden for this information collection is based on over 10 years of experience conducting the NYTS. The planned information collection involves administration of the NYTS electronic pilot questionnaire (Attachment I1) to independent samples of students in the spring of 2017. Respondents include state-level, district-level, and school-level administrators who provide information in the Recruitment Scripts for the NYTS (Attachments E1, F1, and G1), teachers who complete the Data Collection Checklist for the NYTS (Attachment H1).

For the 2017 pilot cycle of data collection, the total number of respondents, by type, will include: state-level administrators (n=6), district-level administrators (n=45), and school-level administrators (n=64) who provide information in the Recruitment Script for the NYTS electronic pilot; teachers (n=292) who complete the Data Collection Checklist for the NYTS electronic pilot; and students (n=6,100) who receive instructions for and complete the NYTS electronic pilot. There are no costs to respondents except their time.

The total burden estimated for the NYTS electronic pilot and associated support activities is 3,689 hours. The totals for this cycle are provided in Table 1.

Table A.12a - Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. ofRespondents	No. of Responses per Respondent	Average Burden Per Response (In Hours)	Total Burden (In Hours)
State Administrators	State-level Recruitment Script for the National Youth Tobacco Survey	6	1	30/60	3
District Administrators	District-level Recruitment Script for the National Youth Tobacco Survey	45	1	30/60	23
School Administrators	School-level Recruitment Script for the National Youth Tobacco Survey	64	1	30/60	32
Teachers	Data Collection Checklist for the National Youth Tobacco Survey	292	1	15/60	73
Students	National Youth Tobacco Survey	6,100	1	35/60	3,558
	Total				3,689

There are no direct costs to the respondents themselves or to participating schools. However, the cost for administrators, teachers, and students can be calculated in terms of their time. In each category, the estimated respondent burden hours have been multiplied by an estimated average hourly salary for persons in that category. The U.S. Bureau of Labor Statistics is the source for hourly wages (http://www.bls.gov/oes/current/oes_nat.htm) (U.S. Bureau of Labor Statistics, 2014). The estimated burden cost in terms of the value of time students spend in responding are based on a minimum wage for students aged less than 20 years of $4.25/hour. The total estimated respondent burden cost for conducting the 2017 NYTS is $80,944.

Table A.12b - Estimated Annualized Burden Costs

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden Per Response (In Hours)	Hourly Wage Rate	Total Respondent Costs
State Administrators	State-level Recruitment Script for the National Youth Tobacco Survey	6	1	30/60	$43.36	$130.08
District Administrators	District-level Recruitment Script for the National Youth Tobacco Survey	45	1	30/60	$58.18	$1,309.05
School Administrators	School-level Recruitment Script for the National Youth Tobacco Survey	64	1	30/60	$43.59	$1,394.88
Teachers	Data Collection Checklist for the National Youth Tobacco Survey	292	1	15/60	$27.55	$2,011.15
Students	National Youth Tobacco Survey	6,100	1	35/60	$4.25	$15,122.92
	Total					$19,968.08

A.13. ESTIMATES OF OTHER TOTAL ANNUAL COST BURDEN TO RESPONDENTS OR RECORD KEEPERS

There will be no respondent capital and maintenance costs. All capital and start-up costs including, but not limited to sampling, record maintenance, and information collection are included in the annualized costs to the government (see section A.14).

A.14. ANNUALIZED COSTS TO THE GOVERNMENT

The study is funded under Contract No. GS-23F-9777H. The total contract award to Deloitte Consulting to conduct the 2017 NYTS electronic pilot is $­­­­893,303. These costs cover the activities in Table 3 below. Some activities will be conducted during the pre-clearance period and others will occur post-clearance.

Additional costs will be incurred indirectly by the government in personnel costs of staff involved in oversight of the study and in conducting data analysis. It is estimated that two CDC employees will be involved for approximately 20% and 35% of their time (for federal personnel 100% time = 2,080 hours annually) at salaries of $58.09 and $46.43 per hour, respectively. The direct annual costs in CDC staff time will be approximately $24,248 + $33,915 = $58,163 annually. The total estimated annualized cost for the study, including the contract cost and federal government personnel cost, is $951,466.

Table A,14a - Annualized Study Cost

Activity	Cost
Contract Costs
Core Team Labor – Planning, Training, Evaluation	$476,125
Dedicated Data Collection Teams	$230,400
Travel – Data Collection	$86,778
Computer Tablet/Licensing	$60,000
School Compensation for Survey Completion	$25,000
Tablet Logistics	$15,000
Subtotal	$893,303
Federal Employee Time Cost
20% time for one FTE	$24,248
35% time for one FTE	$33,915
Subtotal	$58,163
Total Estimated Annualized Cost to the Federal Government	$951,466

*Components may not sum to this figure due to rounding.

A.15. EXPLANATION FOR PROGRAM CHANGES OR ADJUSTMENTS

This is a new data/information collection.

A. 16. PLANS FOR TABULATION AND PUBLICATION AND PROJECT TIME SCHEDULE

Data will be tabulated in ways that will address the principal research purposes outlined in A.2. The planned analyses to be conducted are described briefly below:

1. Estimate the prevalence of tobacco use behaviors and behavioral determinants among middle and high school students overall and by sex, grade in school, and race/ethnicity--Descriptive statistics (percentages and confidence intervals) will be calculated to address this objective.

2. Assess whether tobacco use behaviors and behavioral determinants vary by sex, grade in school, and race/ethnicity--Cross tabulations, Chi-squared analyses, and regression analysis initially will be conducted to address this objective.

3. Determine the associations between tobacco use behaviors and behavioral determinants –Chi-squared and logistic regression analyses will be used.

4. Describe trends in tobacco use behaviors and behavioral determinants among middle and high school students overall and by sex, grade in school, and race/ethnicity--Multiple regression analyses that controls for sex, grade in school, and race/ethnicity and that simultaneously assesses linear and higher order time effects will be used.

5. Examine the effects of schools and local areas (school districts or PSUs) in estimating the prevalence of tobacco use-- multilevel models will be used.

Examples of the table shells that will be completed through analysis of the data are in Attachment K.

CDC’s publication of data from prior cycles of NYTS was largely limited to the MMWR. The 2000 YTS and NYTS data and 2001-2002 YTS and NYTS data were published as MMWR Surveillance Summaries (CDC, 2001). Selected results from the 2004 NYTS were reported in an MMWR weekly article (CDC, 2005). Another weekly MMWR article published in 2009 presented NYTS data on cigarette brand preference among middle and high school students who are established smokers also were published (CDC, 2009). Trend analyses on the use of tobacco by middle and high schools students from 2000-2009 was cited in a special MMWR published in August of 2010 (CDC, 2010). Updated data on current tobacco use among middle and high school students was published in a weekly MMWR summary in 2012 (CDC, 2012a). Two weekly MMWRs were published in 2013 describing e-cigarette use among middle and high school students (CDC, 2013a) and another report provided an overview of all tobacco product use among this population (CDC, 2013b). CDC will continue to publish NYTS results initially through the MMWR, which will be distributed to other Federal agencies, state and local health and education agencies, national health and education organizations, universities, and the general public. Additionally, NYTS results and a public use data set are available on the CDC web site at: http://www.cdc.gov/tobacco/data_statistics/surveys/NYTS/index.htm.

CDC and FDA also have released NYTS results through a variety of government publications, websites, peer-reviewed scientific journals, and annual conferences of national organizations focused on tobacco use, prevention and control, preventive medicine, public health, adolescent health, and epidemiology. A recent supplement was published in the American Journal of Preventive Medicine, with eight research articles co-authored by CDC and FDA describing new findings from the 2012 NYTS. An article was published in JAMA Pediatrics (Dutra & Glantz, 2014) to examine e-cigarette use and conventional cigarette smoking. In addition, data from the NYTS from 2000 through 2012 were used to assess patterns and trends of current tobacco use (cigarettes, cigars, and other tobacco products) among U.S. high school students (Arrazola et al., 2013). CDC hosted a podcast summarizing data on the popularity of emerging tobacco products, including e-cigarettes, among middle and high school students (Arrazola, R.A., 2013).

For the Pilot version of the survey, the results of the comparison to the PAPI NYTS will likely be a focus of publication efforts. The nature of the comparison will likely be of interest to a number of survey specialty groups.

The following represents our proposed schedule of activities for the NYTS, in terms of months after receipt of OMB clearance. The end date for data collection is constrained by the dates on which schools close for the summer. In addition, given that some twelfth grade students may be absent during the final weeks of the school year, it is highly desirable to complete data collection two months before schools close for the summer; i.e., by the end of March.

Key project dates will occur during the following time periods for the 2017 data collection:

Activity	Time Period
Recruit and schedule schools	1 to 3 months after OMB clearance
Pre-install survey software on computer tablets	1 to 2 months after OMB clearance
Train field data collectors	2 months after OMB clearance
Collect data	2 to 5 months after OMB clearance
Process data	3 to 6 months after OMB clearance
Weight/clean data	7 to 8 months after OMB clearance
Produce data file with documentation	9 months after OMB clearance
Analyze data	10 to 11 months after OMB clearance
Publish results	15 to 17 months after OMB clearance

Data collection is currently scheduled to occur during January through March, 2015. The time schedule for the 2017 and 2018 data collection will be analogous to that of the 2015 data collection. Results will be published in early 2018 initially in the MMWR, and subsequently in other publications.

A.17. REASON(S) DISPLAY OF OMB EXPIRATION DATE IS INAPPROPRIATE

The display of the OMB expiration date is not inappropriate.

A.18. EXCEPTIONS TO CERTIFICATION FOR PAPERWORK REDUCTION ACT SUBMISSIONS

There are no exceptions to the certification.

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