0856 NQDW_SSA_clean

NATIONAL QUITLINE DATA WAREHOUSE (NQDW)

(OMB No. 0920-0856, exp. 10/31/2022)

Supporting Statement A

Revision

July 13, 2022

Submitted by:

Epidemiology Branch

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Department of Health and Human Services

Program Official/Contact

Samantha Puvanesarajah

Epidemiology Branch

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Highway, NE S107-7

Atlanta, Georgia 30341

(404) 498-2074

E-mail: [email protected]

TABLE OF CONTENTS

ABSTRACT

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

7. Special Circumstances Relating to 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 Announcement

b. Consultations

9. Explanation of Any Payment or Gift to Respondents

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

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

14. Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

a. Tabulation Plans

b. Publication Plans

c. Time Schedule for the Project

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

REFERENCES

ATTACHMENTS

A-1 Public Health Service Act

A-2. Federal Register Notice

A-3 Federal Register Notice Comments and Agency Responses

B. Consultants on NQDW

 

C-1. NQDW Intake Questionnaire

C-2. NQDW_ASQ Intake Questionnaire_Chinese

C-3. NQDW_ASQ Intake Questionnaire_Korean

C-4. NQDW_ASQ Intake Questionnaire_Vietnamese

D-1. NQDW Intake Questionnaire Subset

D-2 NQDW_ASQ Intake Questionnaire_subset_Chinese

D-3. NQDW_ASQ Intake Questionnaire_subset_Korean

D-4. NQDW_ASQ Intake Questionnaire_subset_Vietnamese

E-1. NQDW_ASQ 7-Month Follow-up Questionnaire_Chinese

E-2. NQDW_ ASQ 7-Month Follow-up Questionnaire_Korean

E-3. NQDW_ASQ 7-Month Follow-up Questionnaire_Vietnamese

E-4. NQDW_ASQ 7-Month Follow-up Questionnaire_English

F. NQDW Quitline Services Survey

G-1. Data Collection Calendar

G-2. Instructions for Submitting NQDW Data to CDC

G-3. Request Email for Submitting NQDW Individual-Level Intake data (for quitlines without outstanding data)

G-4. Request Email for Submitting NQDW Individual-Level Intake data (for quitlines with outstanding data)

G-5. Request Email for Submitting NQDW Individual-Level Intake data and Services Survey data (for quitlines without outstanding data)

G-6. Request Email for Submitting NQDW Individual-Level Intake data and Services Survey data (for quitlines with outstanding data)

G-7. Request Email for Submitting NQDW ASQ 7-month Follow-up data

G-8. Reminder Email Prompt for Non-Respondents for Individual-Level Intake data, Services Survey data, and/or ASQ 7-month Follow-up data

G-9. Reminder Email for Follow-up with Non-Respondents to Repeated Data Requests

H. Sample Table shells

Goal of the study: Since 2010, the National Quitline Data Warehouse (NQDW) has collected a core set of information from the 50 U.S. states, the District of Columbia, Guam, and Puerto Rico regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines. The data collection was modified in 2015 to collect data from the The Asian Smokers’ Quitline (ASQ) in addition to the other 53 states/territories provide data and included five new questions to the NQDW Intake Questionnaire to help CDC and states tailor quitline services to the needs of its callers.

Intended use of the resulting data: CDC uses the information collected by the NQDW extensively for ongoing monitoring, reporting, and evaluation related to state quitlines. Select data from the NQDW are reported online through the CDC’s State Tobacco Activities Tracking and Evaluate (STATE) System website (http://www.cdc.gov/statesystem).

Methods to be used to collect data: Data on participants who received cessation service from state tobacco quitlines is collected from all funded U.S. states, territories and the Asian Smokers’ Quitline (ASQ) through the NQDW Intake Questionnaire. The NQDW Seven-Month Follow-up Questionnaire will be administered to participants who received services from the ASQ only. Seven-month quit rates have been previously estimated for all Quitline callers except those that call the ASQ. Based on previous literature and a review of the follow-up evaluation data previously collected by the NQDW, seven-month quit rates are not expected to change significantly over time. Data on the quitline call volume, number of tobacco users served, and the services offered by state quitlines will be provided by state health department personnel who manage the quitline or their designee, such as contracted quitline service providers, using the NQDW Quitline Services Survey.

Subpopulation to be studied: The NQDW provides data on the general population of people who use tobacco products and contact their state quitlines. Additionally, it also allows for collection of information about key subpopulations who experience tobacco-related disparities, such as pregnant women, uninsured people, and people with behavioral health conditions, who contact state quitlines to better support cessation services.

How data will be analyzed: Simple descriptive data tabulations and trends are currently reported online through CDC’s State Tobacco Activities Tracking and Evaluation (STATE) System website. More complex statistical analyses, including multivariate regression techniques will be utilized to assess quitline outcomes such as quitline reach, service utilization, how callers reported hearing about the quitline, and the effectiveness of quitline promotions and CDC’s Tips From Former Smokers national tobacco education media campaigns on state quitline call volume and people who use tobacco products receiving services from state quitlines.

A.1. CIRCUMSTANCES MAKING THE COLLECTION OF INFORMATION NECESSARY

CDC requests OMB approval to continue information collection for the National Quitline Data Warehouse (NQDW) (OMB No. 0920-0856, exp. 10/31/2022). OMB approval is requested for three years. CDC’s authority to collect information for the NQDW is provided by the Public Health Service Act (Attachment A-1). Activities to improve quitline capacity are supported by funding through the Prevention and Public Health Fund.

The U.S. Surgeon General has concluded that the burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products (USDHHS, 2014). Cigarettes are the most commonly used tobacco product among U.S. adults, and about 480,000 U.S. deaths per year are caused by cigarette smoking and secondhand smoke exposure (CDC, 2018; USDHHS, 2014). In addition, for every person who dies from smoking, 30 additional people suffer from at least one serious smoking-related illness (USDHHS, 2014). Despite these harmful effects, in 2019 an estimated 50.6 million (20.8%) of U.S. adults currently used a tobacco product, including cigarettes (34.1 million), e-cigarettes (10.9 million), cigars (8.7 million), and smokeless tobacco (5.9 million) (Cornelius et al, 2020). Moreover, marked sociodemographic differences in smoking prevalence persist. For example, in 2019, 20.9 % of American Indian/Alaska Native adults reported smoking cigarettes compared to 15.5% of White, non-Hispanic adults, and 35.3% of adults who had earned a GED reported smoking cigarettes compared to 6.9% of adults with an undergraduate degree (Cornelius et al, 2020). Additionally, in 2019, 31.2% of high school students reported current use of any tobacco product (Wang et al., 2019). This was driven primarily by current e-cigarette use, which increased from 1.5% in 2011 to 27.5% in 2019 (Cullen et al., 2018; Cullen et al., 2019).Though current e-cigarette use among youth decreased in 2020, 3.6 million U.S. high school and middle school students (19.6% and 4.7% respectively) still currently used e-cigarettes in 2020 (Gentzke et al., 2020).

Tobacco dependence is a chronic disease that often requires treatment and multiple attempts to quit (Fiore, et al., 2008). As of 2017, a majority of adult smokers tried to quit in almost all states (USDHHS, 2020). Nationally, 55.1% of adult cigarette smokers in 2018 reported making a quit attempt during the past 12 months (Creamer et al., 2019). Quitlines are free services that support quit attempts by providing callers with information, counseling, and referrals. Though quitlines began as telephone-based services, they have evolved over time to incorporate new technologies and now provide services through additional modalities, such as web and texting services. Quitlines have been shown to be an effective, population-based intervention that increases successful quitting (Task Force on Community Preventive Services, 2011). The U.S. Public Health Services’ Clinical Practice Guideline: Treating Tobacco Use and Dependence – 2008 Update, identified quitline counseling (telephone counseling that includes counselor-initiated calls or proactive counseling) as an evidence-based treatment that increased the odds of abstinence by approximately 60% (Fiore, 2008). State-based tobacco cessation quitlines have been shown to be cost-effective (CDC, 2004; Zhu, 2000) and overcome many of the barriers to tobacco cessation classes and traditional clinics because they are free and available at the caller’s convenience.

Publicly funded state quitlines operate in every state, the District of Columbia, Guam, and Puerto Rico. As a result of a collaboration with NCI, callers can be automatically routed to their state quitline by calling 1-800-QUIT-NOW and Spanish-speaking callers can be automatically routed to Spanish-language services through 1-855-DEJELO YA. A national Asian Smoker’s Quitline (ASQ) provides services in Korean, Mandarin, and Vietnamese and conducts direct outreach to speakers of these languages.

The Centers for Disease Control and Prevention (CDC), Office on Smoking and Health (OSH) provides funding and/ or technical assistance to quitlines in 50 states, the District of Columbia, Guam, and Puerto Rico, in addition to the ASQ. Although quitline services and operations vary across states and territories, some activities are based on common protocols that provide a framework for program monitoring and evaluation. A minimum data set (MDS) was developed collaboratively by the quitlines and stakeholders, including professional organizations and CDC, to serve as a core set of information reported by quitlines. Additionally, quitlines have the option of adding state-specific questions and services to their intake or follow-up surveys that CDC does not require to be submitted.

During the most recent OMB approval period, 54 quitlines reported caller intake to CDC through the NQDW. The ASQ also submitted follow-up data to CDC. In addition, each state- or territory-based quitline submitted a semiannual services report which summarized its services, call volume, and caller characteristics.

A.2 PURPOSE AND USE OF INFORMATION COLLECTION

The specific aims of the planned data collection are to:

1. Nationally and by state, determine the population reach of quitlines.

2. Nationally and by state or territory, describe the characteristics of participants who are served by quitlines and determine whether high-risk populations (e.g., pregnant women, racial and ethnic minorities, low socioeconomic status, uninsured or medically underserved, and people with behavioral health conditions) utilize quitline services.

3. Estimate the number and proportion of participants who received treatment from the Asian Smokers’ Quitline who successfully quit (7 month quit rate).

4. Nationally and by state, monitor and assess the services offered by state quitlines.

CDC will continue to use the information collected by the NQDW for ongoing monitoring and evaluation related to state quitlines, including routine tracking of quitline service metrics such as call volume and participants receiving services from quitlines. CDC uses NQDW data to support provision of technical assistance and help identify best practices in quitline operations, which can be used for program improvement. This data helps provide public health and education officials and the general public with accurate information about quit rate trends and use of quitlines. It also is used to inform program development and provide federal and state legislatures with information about the use and effectiveness of quitlines to inform resource allocation for cessation interventions.

In 2012, the U.S. Department of Health and Human Services (USDHHS) initiated the CDC’s Tips From Former Smokers® (Tips®) campaign, the first-ever federally funded national tobacco education media campaign, to increase public awareness of immediate health damage caused by smoking and to encourage adult smokers to quit (www.cdc.gov/tips). Data collected by the NQDW serves an important role in helping CDC assess the effectiveness of the Tips® campaign in promoting the use of quitlines. In 2014, CDC provided approximately $17 million through an Notice of Funding Opportunity (CDC-RFA-DP14-1410PPHF14) to 46 states, DC Guam, and Puerto Rico for a period of 48 months to support state quitline capacity, in order to respond to federal initiatives such as the CDC’s Tips® campaign.

In 2015, CDC also provided funding through the National State-based Tobacco Control Programs (CDC-RFA-DP15-1509) to continue submitting quitline data to the NQDW for a period of 5 years. In 2020, CDC provided approximately $16 million of annual funding through a Notice of Funding Opportunity (CDC-RFA-DP20-2001) to 50 states, DC, Guam, and Puerto Rico for a period of 5 years to continue to ensure and support state quitline capacity, in order to respond to federal initiatives such as the CDC’s Tips® campaign. An essential element of this program includes cessation services provided through quitlines. CDC’s Best Practices for Comprehensive Tobacco Control Programs-2014 is an evidence-based guide designed to help states plan and establish effective tobacco control programs to prevent and reduce tobacco use (CDC, 2014). The Guide’s recommendations for state quitlines include increasing the level of quitline reach within each state to 6%-8%, providing a focus on populations experiencing tobacco-related disparities, providing nicotine replacement therapy through the quitline, and collaborating with health care systems to increase quitline referrals. The Affordable Care Act contains several provisions to improve insurance coverage of evidence-based preventive services, including tobacco cessation. Health insurers and employers use state quitlines to provide evidence-based counseling services.

CDC will continue to make information collected by the NQDW available to federal and state governments, state tobacco control program managers, researchers, and the general public online through the CDC’s State Tobacco Activities Tracking and Evaluate (STATE) System website (http://www.cdc.gov/statesystem).

Uses of Information Collection by Other Federal Agencies and Departments

The data collected as part of the NQDW are of interest not only to CDC, but also to other Federal agencies and departments. The U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services, Food and Drug Administration, National Cancer Institute, Office of National Drug Control Policy and Substance Abuse and Mental Health Services Administration can use NQDW data to help inform regulatory, research, educational efforts, and demonstration projects focused on adult tobacco use cessation, especially related to addressing disparities in access to and use of cessation services.

Uses of Information Collection by Those Outside Federal Agencies

Data collected as part of the NQDW can be used in a variety of ways by state and local governments, researchers, voluntary health organizations, physicians, health educators, workplace wellness programs, and community outreach organizations:

• The legislative and executive branches of government can use NQDW data to evaluate existing quitline programs and use the information to guide program investments.

• National data collected as part of the NQDW will provide an index against which state and local health agencies can compare their state quitline results.

• State and local health departments will use data collected as part of the NQDW as a guide in developing and monitoring state-based indicators for tobacco prevention and control.

• Family physicians, pediatricians, psychologists, and counselors may use data collected as part of the NQDW to provide up-to-date information on quit services and information.

• Health educators and workplace wellness programs may use data collected as part of the NQDW in their curriculum development to provide information on quitline services.

• Health plans/health care systems/insurers can use data collected as part of the NQDW to monitor the utilization and effectiveness of quitlines and compare the cost-effectiveness of quitlines with other covered quit services.

• Professional organizations can use data collected as part of the NQDW to make the case for the importance of tobacco cessation efforts and to monitor the progress of these efforts.

A.3 USE OF IMPROVED INFORMATION TECHNOLOGY AND BURDEN REDUCTION

Each state will determine the types of technology used to conduct intake interviews. The majority of states will use computer assisted telephone interviewing (CATI). Additionally, as new technologies continue to evolve, some states will allow callers to conduct the initial intake interview online and/or via text messaging apps before they are referred to a live counselor. States will be encouraged to use information technology to reduce burden.

States currently submit their individual-level data to CDC’s contractor for NQDW through a secure FTP server site. CDC instituted online data submissions through a secure FTP server as a way to simplify and expedite data submission. Each state is able to approve one or more staff members or designees to use the site, each of whom has their own user ID and unique password. The server is checked several times a week for files and the files are quickly removed after being downloaded. Technical assistance is provided to states to aid in the submission of data to the NQDW.

The NQDW Quitline Services Survey is based on a fillable form-style Microsoft Word document. The survey consists of 22 questions, and the electronic form for the survey includes drop-down boxes, data entry fields, and checkboxes to help reduce data entry errors. Pending approval of this revision request, CDC will request that states complete the new survey in its entirety once, and thereafter will pre-populate the responses to questions 2-15 with the information the state reported for the previous time period. This minimizes burden on survey respondents since states only need to make edits if changes occurred in the services being offered by the quitline since the last time the state responded to the survey.

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

The North American Quitline Consortium (NAQC) is an international, non-profit organization. NAQC conducts an Annual Survey of Quitlines that CDC initially thought might serve some of the agency’s data needs. However, NAQC’s data is collected annually and based on states’ fiscal years. CDC needs to have individual-level intake data quarterly and services data semiannually based on standard calendar periods to evaluate interventions (e.g. CDC Tips®) that may impact quitline utilization. In addition the data submitted to NQDW undergo a quality assurance process to maintain accuracy.

To minimize duplication of effort by CDC and NAQC, in 2011 CDC asked each state/territory for permission to share their quarterly NQDW Quitline Services Online Survey data for 2010 and 2011 with NAQC. Over 95% of the states agreed to this. NAQC can be assured that these data are “clean” when they come from CDC because CDC has verified the various data points at various times with each state/territory. CDC views this as an opportunity to reduce the burden on states (as they will not need to complete similar surveys for CDC and for NAQC) as well as an opportunity to decrease duplication of similar data collection efforts by CDC and NAQC. CDC spent many person-hours on this effort and is willing to make a special effort in the coming years to share data again with NAQC. More recently, in 2019, CDC and NAQC were in close communication about NAQC’s planned changes to the MDS. CDC referenced those changes and the MDS more broadly to ensure that CDC’s proposed changes to the NQDW outlined in this OMB request align. CDC plans to continue this communication on a regular basis in order to ensure the coordination of CDC’s and NAQC’s efforts in this area and to avoid duplication and minimize burden on states.

To further reduce burden on states and to account for the expansion of service provision and data collection modalities in recent years (i.e. from solely phone-based to online and text application capabilities), CDC convened several meetings in 2020 with state quitline representatives from the National Tobacco Control Program. These discussions ensured that CDC’s proposed changes to the NQDW questionnaire and the services survey reflect quitline services as accurately as possible while remaining a minimal collection and reporting burden to states.

It is essential for CDC to have direct control and ready access to these data because CDC provides substantial funding to support state quitline activities and is accountable for the outcomes of these activities. CDC currently uses NQDW data for accountability of CDC funding, to track state quitline program performance, to answer questions posed by members of the U.S. Congress, and to respond to time-sensitive internal and external inquiries regarding the number of tobacco users served by quitlines. NQDW data can also be used to evaluate the effectiveness of CDC’s Tips® national tobacco education media campaigns on promoting calls to, and use of, state quitlines.

A.5 IMPACT ON SMALL BUSINESSES OR OTHER SMALL ENTITIES

The planned data collection does not involve small businesses or other small entities.

A.6 CONSEQUENCES OF COLLECTING THE INFORMATION LESS FREQUENTLY

The NQDW collects NQDW Quitline Services Survey data from states on a semiannual basis based on the calendar year. As such, CDC is obtaining data on call volume and the number of tobacco users receiving services every six months. While CDC previously obtained data on services offered by quarter, beginning in 2019 CDC obtains these data semiannually and publishes NQDW data in the STATE System twice per year. Collecting these data less frequently would adversely affect CDC’s ability to release semiannual data from the NQDW on the STATE System in an ongoing, and timely, manner. Additionally, there is a large seasonality effect with respect to quitline utilization. Because of the seasonality of quitline utilization as well as the need to monitor the impact of the Tips® media campaigns on state quitline call volume and tobacco users registering for services from state quitlines, CDC believes it is important to collect information on call volume on a more frequent basis than annual data collection. Finally, during the past several years states have been changing their service mix (e.g., providing medication in some quarters and not others) during the course of the year, which confirms the need for data collection more frequently than annually. The NQDW data collection is intended as continuous data collection. As noted above, the resulting information will provide critical information at the state and national levels for ongoing evaluation and monitoring purposes. The CDC and quitline stakeholders use the NQDW data to demonstrate the role quitlines play in promoting tobacco use cessation, to measure the number of tobacco users being served by state quitlines, and to improve quitline operations, service quality, and access; more granular (quarterly/semiannual) data is necessary to inform the future of quitlines as well as future federal investments.

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.8.a Federal Register Notice

A 60-day Federal Register Notice was published in the Federal Register on 07/07/21, volume 86, no 127, pages 35797-35798 (Attachment A-2).

CDC received 3 substantive comments. CDC responses to these comments are provided in Attachment A-3.

A.8.b Consultations

CDC continues to consult with partner organizations including the North American Quitline Consortium (NAQC) to explore ways to increase utility of NQDW and reduce reporting burden. CDC has had ongoing conversations with NAQC regarding alignment of the data collection instruments as well as data sharing. CDC leaders also engaged quitline stakeholders including service providers to gain a better understanding of the evolving quitline service provision.

During 2017-2018, as part of a strategic planning process to inform OSH’s future tobacco cessation priorities and activities, OSH solicited input on challenges and needs in this area from a wide range of stakeholders, including state tobacco control programs, national partners (including NAQC), and quitline providers (Attachment B). This was done through a variety of methods, including calls, meetings, visits, and a federal register notice. This included seeking input on OSH’s quitline activities, including the NQDW.

The information collected through this process was used to develop a strategic plan for OSH’s future cessation activities and an operational plan for implementing these activities. The feedback gathered from stakeholders on the NQDW was used to identify several priorities for improving NQDW, including improving the quality of NQDW data, increasing the utility of this data, modernizing NQDW, and drawing on NQDW data to demonstrate the value of state quitlines.

As part of its efforts to increase the utility of NQDW data and modernize the NQDW in order to better demonstrate the value of state quitlines, during 2020-2021, OSH conducted a thorough review of the existing NQDW survey instruments and identified opportunities for improvement. As part of an inclusive planning process to inform proposed changes to the NQDW survey instruments, OSH solicited input from CDC subject matter experts and stakeholders on how best to refine the survey instruments to address data gaps, such as the use of e-cigarettes, and to capture information on quitline services provided through new technologies. Stakeholders included state tobacco control programs, quitline and cessation subject matter experts, national partners (including NACQ), and quitline providers (Attachment B). This was done through a variety of methods, including calls, meetings, and a federal register notice.

The information collected through this process was used to inform the modifications to the NQDW intake questionnaire and Services Survey put forth in this change request.

A.9 EXPLANATION OF ANY PAYMENT OR GIFT TO RESPONDENTS

No payment or gifts are provided to respondents.

A.10 PROTECTION OF THE PRIVACY AND CONFIDENTIALITY OF INFORMATION PROVIDED BY RESPONDENTS

The Privacy Act does not apply to this information collection. CDC does not collect or receive information in identifiable form (IIF), nor can CDC retrieve the data by IIF data elements. CDC requests only a subset of de-identified client-level information, including some demographic data. The de-identified information is adequate for CDC/NQDW objectives.

Overview of the Data Collection System. The NQDW Intake questionnaire will collect data on tobacco use, intention to quit, previous success with quitting, and use of counseling and/or medications to facilitate or maintain quit. The Seven-Month Follow-up Questionnaire will also collect similar data but only for those who received services from the Asian Smokers’ Quitline (ASQ). These topics are generally regarded as being no greater than minimally sensitive. Participation in the intake interview is voluntary but an intrinsic part of seeking services. Participation in the 7-month follow-up interview is completely voluntary. Through the NQDW, CDC receives only de-identified common data elements. Intake data is only reported in aggregate in the CDC STATE System to prevent any inadvertent identification of participants due to small cell sizes. The NQDW Quitline Services Survey gathers the types of information regarding services from state-based quitlines in tobacco control programs; therefore, this information is not considered sensitive. Therefore, all three data collections will have little or no effect on respondent’s privacy.

Although the ASQ will collect information in IIF, such as name and telephone number, these data are for their operational purposes independent of what is requested to be reported to the NQDW and will be used to generate advance letters to ASQ quitline participants selected for the 7-month follow-up. The IIF will not be transmitted to CDC, and IIF will not be linked to response data.

Quitlines are state-based services. CDC provides cooperative agreement funding and technical assistance to help states/territories strengthen those services and to facilitate the collection of common data elements. States/territories devise their own strategies for delivering quitline services, and the ASQ devises its own strategies for contacting quitline participants for the NQDW Seven-Month Follow-up Questionnaire. Information on state-specific operating procedures is not requested as part of the NQDW. Nevertheless, safeguards will be put in place to ensure that all collected data remain secure (e.g., following protocols for minimum cell sizes for reporting on findings) (http://www.cdc.gov/nchs/).

Data for the NQDW Intake Questionnaire and Seven-Month Follow-up Questionnaire will be collected from participants primarily by telephone, including but not limited to CATI. Some intake data will also be collected via the web and potentially via text. CDC is recommending that states continue collecting the intake data using the same media that they are currently using. This is because the states have determined that these methods are the best to collect the data without disrupting the provision of services (the primary goal of the quitlines). Data from the NQDW Intake Questionnaire and Seven-Month Follow-up Questionnaire are submitted to CDC’s contractor via a secure NQDW FTP server. The NQDW Quitline Services Survey will be completed electronically using a form-style Microsoft Word document. Completed surveys will be returned to CDC’s contractor via email or submitted through the secure FTP site.

Items of Information to be Collected. The NQDW utilizes four instruments: the NQDW Intake Questionnaire (Attachments C-1 to C-4); the NQDW Intake Questionnaire for the subset of participants who are calling for someone else (Attachments D-1 to D-4); the NQDW Seven-Month Follow-up Questionnaire for tobacco users who received services from the Asian Smokers’ Quitline (Attachments E-1 to E-4); and the NQDW Quitline Services Survey (Attachment F). CDC Best Practices for Comprehensive Tobacco Control Programs – 2014 recommends that quitlines should place specific focus on populations with disproportionate tobacco use (CDC, 2014), and many state quitlines are either specifically targeting populations with disproportionately high tobacco use or provide additional quitline services to those populations (such as additional counseling or free quitting medications). Two questions have been added to the NQDW intake questionnaire to capture information on participants of two such populations (LGBT and military), and one question has been added to the Services Survey to allow states to report on the provision of cessation protocols tailored for specific populations with disproportionately high tobacco use.

The NQDW Seven-Month Follow-up Questionnaire will be completed for tobacco users who completed an NQDW Intake Questionnaire and received a service from the Asian Smokers’ Quitline (ASQ). The survey asks questions about quitline service satisfaction, whether or not the participant has quit using tobacco, duration of quitting if applicable, use of products and/or medication to help quit, and use of non-quitline assistance to quit.

Respondents for the NQDW Quitline Services Survey are state health department personnel (e.g., state tobacco control managers, state cessation coordinators, state quitline managers – not private quitline service providers) or their designee, which might include quitline service providers, such as Optum or National Jewish Health, in 50 states, the District of Columbia, Guam, Puerto Rico, and for ASQ. The survey asks questions about: (a) the name of the state’s quitline; (b) the phone numbers used by the state’s quitline; (c) the quitline’s hours of operation; (d) available counseling languages offered by the quitline; (e) eligibility criteria for receiving counseling from the quitline; (f) the amount of counseling offered by the quitline; (g) free quitting medications that are offered by the quitline; (h) eligibility criteria to receive free quitting medications from the quitline; (i) the amount of free quitting medications offered by the quitline; (j) how participants heard about the quitline; (k) service modalities; (l) population-specific cessation protocols; (m) call volume, (n) number of unique callers, (o) number of web visits, (p) referral sources, (q) number of referrals received by the quitline, (r) service utilization, and (s) number of completed registrations.

Data Security. Precautions will be taken in how the data are handled to prevent a breach of privacy. Survey data and all identifying information about respondents will be handled in ways that prevent unauthorized access at any point during the data collection and management process. OSH does not request any Personally identifiable information (PII) from the states or territories, and data collection requests to states and territories specify that all data submitted to the NQDW should be de-identified data. No individual-level data are made available to the public and no identifiable data are included in CDC studies, reports, or publications. Respondents will be told during the quitline registration that the information they provide will be kept secure. All interviewers will be required to sign a non-disclosure agreement on the date of hire, which will be reinforced at training.

Consent. Verbal consent will be elicited from participants in the NQDW Seven-Month Follow-up with ASQ. Before each follow-up interview, the interviewer will read the informed consent script to each participant. The consent script describes the interview and the types of questions that will be asked on the actual survey. The consent script 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.

A.11 INSTITUTIONAL REVIEW BOARD (IRB) AND JUSTIFICATION FOR SENSITIVE QUESTIONS

IRB Approval

This information collection is a program evaluation activity, not research. IRB approval is not required.

Sensitive Questions

On the NQDW intake questionnaire, 35 of 50 questions are tobacco-related. Similarly, on the NQDW 7-month follow-up questionnaire, 26 of 28 questions are tobacco-related. The items are typically not of a sensitive nature and are commonly found in surveys on tobacco use. Data on tobacco use are generally regarded as being no greater than minimally sensitive. Most importantly, each individual who completes the NQDW intake questionnaire is seeking assistance with tobacco cessation and providing intake data is part of service provision. The intake process and counseling protocols cannot be completed without asking about tobacco use history. Similarly, the NQDW Seven-Month Follow-up Questionnaire will be conducted among participants seeking services from the ASQ in order to assess the effectiveness of its services. Although follow-up data are used to calculate a quit rate and determine what factors contribute to variability in quit rates, participation in the follow-up interview can identify needs for additional services; however, in the clinical context of the follow-up interview, these data are minimally or not at all sensitive.

The proposed NQDW intake questionnaire also includes twelve demographic questions, one question about each of the following: sexual orientation and gender identity (2 questions), year respondent was born, zip code, level of education, insurance status, ethnicity, race, pregnancy status (for females), behavioral health conditions, and military status. OMB considers questions about race and ethnicity, sexual orientation, and gender identity to be sensitive, but not highly sensitive. None of the data reported on the NQDW Quitline Services Survey by CDC grantees is sensitive because these kinds of data are normally reported by grantees to maintain accountability in use of government resources. Therefore, the data collection will have little or no effect on a respondent’s privacy. Nevertheless, safeguards will be put in place to ensure that all collected data remain secure.

A.12 ESTIMATES OF ANNUALIZED BURDEN HOURS AND COSTS

Estimated Burden Hours

OMB approval is requested for three years. The annualized estimates for the number of respondents and burden hours for this proposed OMB revision are summarized in Table A.12.a below. The expected number of quitlines reporting data to the NQDW in future OMB approval periods will be 54 (50 states, the District of Columbia, Guam, Puerto Rico, and the ASQ). The burden table includes allocations for the time that the 50 states, DC, Guam, Puerto Rico, and the ASQ spend administering intake and follow-up interviews (ASQ only) to quitline callers. The burden table also includes allocations for the 50 states, DC, Guam, Puerto Rico, and the ASQ to compile and submit aggregate files and service summaries to CDC.

Two versions of the NQDW Intake Questionnaire will be administered to participants through Computer-Assisted Telephone Interview (CATI) or via online methods. The complete questionnaire will be administered to participants who contact a quitline on their own behalf. The complete intake questionnaire will be administered by the 50 states, DC, Guam, and Puerto Rico (see Attachment C-1, in English). The estimated number of respondents is 405,053 based on 2019 caller data and feedback from a key vendor indicating that 72% of respondents complete the intake questionnaire over the phone versus 28% who complete it online; approximately 291,638 participants called into a quitline in 2019, indicating that an estimated 405,053 total participants completed the questionnaire (291,638*100/72 = 405,053). Pending approval of this revision request, quitlines will be able to begin reporting on the estimated 113,415 participants that completed the questionnaire online (405,053-291,638=113,415).

Participants who prefer to receive quitline services in Chinese, Korean, or Vietnamese will be referred to the Asian Smokers Quitline (see Attachments C-2 to C-4). The estimated number of respondents for the ASQ is 1,686, based on data from 2019 and web-use expectations. For all participants, the estimated burden per response for a complete intake call is 10 minutes.

An abbreviated version of the Intake Questionnaire will be administered to participants who contact the quitline on behalf of another person (approximately 0.3%, which is an estimated 1,068 per year). Of these participants, 819 will be served through 50 states, DC, Guam, or Puerto Rico (see Attachment D-1, in English) and 249 will be served through the ASQ (see Attachment D-2, D-3, and D-4 in Chinese, Korean, and Vietnamese, respectively). The abbreviated version consists of the first three questions of the intake interview. The estimated burden per response for these participants is 1 minute.

The Asian Smokers Quitline will administer a 7-Month Follow-up Questionnaire to participants who complete their intake call through the ASQ (see Attachment E-1 to E-3). An English language version of the 7-Month Follow-up Questionnaire is included for reference but will not be administered by the ASQ (see Attachment E-4). Similarly, although this revision request includes changes to the Intake Questionnaire and the Services Survey, it does not include any revisions to the ASQ’s materials, nor does it include changes to burden hours related to ASQ materials. The estimated burden per response is 7 minutes. CDC estimates the burden of seven minutes should remain consistent with the English language survey since the same questionnaire is being used. NQDW ASQ Seven-Month Follow-up Questionnaire interviews are collected primarily by telephone, including but not limited to Computer Assisted Telephone Interviews (CATI). The ASQ is the only service provider that will submit 7-Month Follow-up information to CDC. An estimated 236 tobacco users who called the ASQ for themselves and received services will complete the NQDW Seven-Month Follow-up Questionnaire. The ASQ issues the 7-Month Follow-Up questionnaire randomly to 20% of tobacco users annually who call the ASQ for themselves and receive services from the ASQ and has a 70% completion rate (1,686*.20*.70=236).

The NQDW Quitline Services Survey (Attachment F) will be administered 2 times per year (Attachment G-1) to state health department personnel (e.g., state tobacco control managers, state cessation coordinators, state quitline managers – not private quitline service providers) or their designee, which might include quitline service providers such as the ASQ, in 50 states, the District of Columbia, Guam, Puerto Rico, and for the Asian Smokers’ Quitline.

On a quarterly basis (Attachment G-1), the state tobacco control program manager or their designee, such as a quitline service provider, is responsible for providing CDC with a de-identified electronic data file containing data records for individuals who completed the NQDW Intake Questionnaire (Attachment C-1). The proposed questionnaire (see Section A.15) consists of 50 questions, 35 of which are related to tobacco and nicotine products. The first part of the survey (questions 1-3) asks about the purpose of the contact and how the respondent was referred to the quitline. Questions 4-38 consist of items regarding: (a) recent tobacco product use; (b) frequency of tobacco product use; (c) quantity of tobacco products used; (d) date of last use; (e) timing of the first cigarette use of the day; and (f) intention to quit. The final 12 questions (39-50) consist of participant characteristics, such as: (g) sexual orientation; (h) gender identity; (i) year respondent was born; (j) zip code; (k) level of education; (l) insurance status; (m) ethnicity; (n) race; (o) pregnancy status (for females); (p) behavioral health conditions; and (q) military status. The questionnaire instructions also include skip patterns and branch logic to reduce the number of questions asked and lower respondent burden. Thus, the estimated burden per response remains 10 minutes, consistent with the estimate from the prior OMB approval period. The total estimated annualized burden to respondents is 67,509 hours.

In addition to the burden per respondent for completing the NQDW Intake Questionnaire, CDC also reports the estimated burden for creating electronic data files and submitting those to the NQDW. The burden for preparing and submitting the electronic data file for the NQDW Intake Questionnaire, by uploading the electronic data file to CDC’s contractor’s secure NQDW FTP server (Attachment G-2), has been estimated as 1 hour per electronic data file submitted (4 times per year).

On an annual basis (Attachment G-1), a representative from the ASQ is responsible for providing CDC with an electronic data file containing de-identified data records for individuals who completed the NQDW ASQ Seven-Month Follow-up Questionnaire. These electronic data files are compiled from the ASQ’s quitline data system, which is supported by state funding sources supplemented by cooperative agreement assistance from CDC. In addition to the burden per respondent for completing the NQDW ASQ Seven-Month Follow-up Questionnaire, CDC also estimated and reports the burden for creating electronic data files and submitting those to the NQDW. The burden for preparing and submitting the electronic data file for the NQDW ASQ Seven-Month Follow-up Questionnaire, by uploading the electronic data file to CDC’s contractor’s secure NQDW FTP server, has been estimated as 1 hour per electronic data file submitted (1 hour per year).

The NQDW Quitline Services Survey (Attachment F) collects aggregate information, on a twice-yearly schedule, about the services offered by the state quitline, rather than individual-level information from tobacco users receiving services from quitlines. CDC will request that 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smokers’ Quitline (ASQ) complete the survey every six months, for a total number of 54 respondents per semiannual period. The NQDW Quitline Services Survey instruments are state-specific fillable form-style Microsoft Word documents that CDC prepares every six months for states to complete. The survey consists of 22 questions, and the electronic form for the survey includes drop-down boxes, data entry fields, and checkboxes to help reduce data entry errors. The first part of the survey (questions 1-15) consists of collecting respondent contact information and survey questions regarding the services offered by the state’s quitline: (a) the name of the state’s quitline; (b) the phone numbers used by the state’s quitline; (c) the quitline’s hours of operation; (d) available counseling languages offered by the quitline; (e) eligibility criteria for receiving counseling from the quitline; (f) the amount of counseling offered by the quitline; (g) free quitting medications that are offered by the quitline; (h) eligibility criteria to receive free quitting medications from the quitline; (i) the amount of free quitting medications offered by the quitline; (j) how participants heard about the quitline; (k) service modalities; and, (l) population-specific cessation protocols. Quitline services offered do not typically change much within a year for a given state, and consequently, responses to these questions tend to remain the same. To reduce burden on survey respondents, CDC will pre-populate the responses to questions 2-15 with the information the state reported for the previous semiannual period. As this revision request includes an updated NQDW Quitline Services Survey, the first implementation of the new form will include no pre-populated responses; pre-population will resume after this first data collection. States are asked to review their previous responses to those questions and make edits if there were any changes in the services being offered by the quitline since the last time the state responded to the survey.

The second part of the survey (questions 16-22) consists of questions regarding the state’s quitline (a) call volume, (b) number of unique callers, (c) number of web visits, (d) referral sources, (e) number of referrals received by the quitline, (f) service utilization, and (g) number of completed registrations. The estimated burden per response is 20 minutes and is based on states’ experiences completing these survey forms over the past ten years. Although the revised survey contains five more questions in sum (17 to 22), the number of questions that are not pre-populated only increased by one (from 6 to 7). As the changes to the survey also reflect stakeholders’ perceptions of appropriate burden, desire to capture information on quitline services provided through different modalities, and improved guidance for responses, the estimated burden is expected to remain consistent with prior years.

Requests for data are emailed to the state tobacco control program manager or their designee, such as a quitline service provider, and the ASQ representative in advance of the submission deadlines (Attachments G-1 and G-3 to G-7). Follow-up emails reminding respondents of outstanding data are sent according to the NQDW Data Request Follow-up Schedule (Attachments G-1 and G-8 to G-9).

The total estimated annualized burden across all types of respondents and forms is 68,089 hours.

Table A.12.a. Estimated Annualized Burden Hours

Type of respondent	Form Name	Number of respondents	Number of responses per respondent	Average burden per respondent (in hours)	Total burden (in hours)
Quitline participants who contact the quitline for help for themselves	NQDW Intake Questionnaire (English-complete)	405,053	1	10/60	67,509
	ASQ Intake Questionnaire (Chinese, Korean, or Vietnamese-complete)	1,686	1	10/60	281
	ASQ Seven-Month Follow-up Questionnaire	236	1	7/60	28
Participants who contact the quitline on behalf of someone else	NQDW Intake Questionnaire (English-subset)	819	1	1/60	14
	ASQ Intake Questionnaire (Chinese, Korean, or Vietnamese-subset)	249	1	1/60	4
Tobacco Control Manager or their Designee / quitline Service Provider	Submission of NQDW Intake Questionnaire Electronic Data File to CDC	54	4	1	216
	Submission of NQDW (ASQ) Seven-Month Follow-up Electronic Data File to CDC	1	1	1	1
	NQDW Quitline Services Survey	54	2	20/60	36
	Total				68,089

The burden estimates for individual-level information collection are based on the length of the CATI interviews and web-based interactions with participants. The majority of states have contracts with private-sector quitline service providers to manage the information collected through the CATI systems and other intake questionnaire modalities. The data management, cleaning, and reporting activities conducted by quitline service providers are accounted for in their contractual agreements with states, and do not represent burden to the public. CDC allows states to use cooperative agreement funding to support these contracts. As quality improvement and cost containment measures, CDC provides substantial technical assistance to states to support and streamline these processes.

A.12.b Estimated Annualized Cost to Respondents

There are no direct costs to the respondents in this planned data collection. Indirect costs to adult respondents can be calculated in terms of the time required to respond to the three questionnaires, including tobacco product users taking ten minutes to complete the Intake Questionnaire, ASQ-enrollees taking seven minutes to respond to the Seven-Month Follow-up Questionnaire, or state health department employees taking twenty minutes to complete the Services Survey. For these calculations, CDC used the average hourly wage rate of $25.72/hour (estimated mean of all industry earnings, May 2020, U.S. Department of Labor). Reporting on the NQDW Quitline Services Survey is a requirement of The CDC core cooperative agreement for state tobacco control programs as well as CDC cooperative agreements that specifically provide funding for quitlines. These awards provide compensation for the cost of the state health department personnel’s time. The total estimated annualized cost to respondents is $1,841,122 .

Table A-12.b. Annualized Estimated Cost to Respondents

Type of respondent	Form Name	Number of respondents	Total Burden (in hours)	Average Hourly Wage	Total cost
Quitline participants who contact the quitline for help for themselves	NQDW Intake Questionnaire (English-complete)	405,053	67,509	$27.04	$1,825,439
	NQDW (ASQ) Intake Questionnaire (Chinese, Korean, or Vietnamese-complete)	1,686	281	$27.04	$7,598
	NQDW (ASQ) Seven-Month Follow-up Questionnaire	236	28	$27.04	$757
Participants who contact the quitline on behalf of someone else	NQDW Intake Questionnaire (English-subset)	819	14	$27.04	$379
	NQDW (ASQ) Intake Questionnaire (Chinese, Korean, or Vietnamese-subset)	249	4	$27.04	$108
Tobacco Control Manager or their Designee / Quitline Service Provider (such as the Asian Smokers’ Quitline)	Submission of NQDW Intake Questionnaire Electronic Data File to CDC	54	216	$27.04	$5,841
	Submission of NQDW Seven-Month Follow-up Electronic Data File to CDC	1	1	$27.04	$27
	NQDW Quitline Services Survey	54	36	$27.04	$973
	Total				$1,841,122

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

There will be no respondent capital and maintenance costs.

A.14 ANNUALIZED COSTS TO THE GOVERNMENT

CDC will have contract costs to create the database, clean and process the data, provide technical assistance to states on data collection, and report on the data of $394,273 annually. 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. The direct annual costs in CDC staff time will be approximately $142,989 annually.

Activity	Yearly Costs
Annual Contract Costs
Data collection, processing and analysis	$394,273
Subtotal	$394,273
Annual Personnel Costs (Federal Employee Time Cost)
5% time – GS14 FTE @ $143,867	$7,193
5% time – GS13 FTE @ $124,955	$6,248
5% time – GS13 FTE @ $108,934	$5,447
80% time – GS13 FTE @ $108,934	$87,147
20% time – GS12 FTE @ $91,609	$18,322
50% time – CCO – 04 FTE @ $37,264	$18,632
Subtotal	$142,989
Grantee Costs
5% of grantee’s program cost (quitline funding)	$800,000
Subtotal	$800,000
Total Annualized Cost to the Government	$1,337,262

The annualized cost to the government for the NQDW data collection, processing, and analysis will be $1,337,262. The 36-month cost to the government for the NQDW data collection, processing, and analysis will be $4,011,786.

A.15 EXPLANATION FOR PROGRAM CHANGES OR ADJUSTMENTS

The total estimated annual burden hours for the proposed OMB revision is 68,089, which is 14,351 hours fewer than the 82,440 estimated annual burden hours in the previous OMB approval period. As noted in Section A.12, the estimated number of respondents changed for the NQDW Intake Questionnaire based on assessment of 2019 quitline data and accounting for completion of the instrument through other modalities (e.g. online). The estimated number of respondents for the ASQ Seven-Month Follow-up Questionnaire changed based on assessment of response rates. There are no changes to the estimated burden per response for any of the information collection instruments; this is described further in the following paragraphs.., As described in Section A.8.b, OSH conducted a thorough review of the existing NQDW survey instruments during 2020-2021 and identified opportunities to refine and improve the instruments and address data gaps. Based on this process. CDC proposes the following changes to the NQDW Intake Questionnaire and the NQDW Services Survey; these are described in the following paragraphs.

NQDW Intake Questionnaire: CDC proposes to add 12 questions and to remove 4 questions from this instrument. Added questions pertain to use of e-cigarettes (5) and intent to quit e-cigarettes; use of menthol cigarettes and menthol e-cigarettes, sexual orientation, gender identity (2), and military status. Removed questions pertain to purpose of the call, prior calls, verification of male or female sex, and insurance status; in addition, language pertaining with caller’s intent to continue with call also was deleted. The proposed questionnaire has 50 questions as compared to 42 questions on the present questionnaire. In addition, minor modifications to the questionnaire are proposed as follows: a) minor edits to 18 questions, either to question text or response categories; b) re-ordering of responses for race and ethnicity questions to align with OMB guidance; and c) minor edits related to follow-up consent and administrative data.

The proposed additional questions are relevant due to data gaps in the present survey. There are no questions related to e-cigarettes on the present survey. In 2018 3.2% of U.S. adults and over 20% of high school students were current e-cigarette users (Creamer et al., 2018; Cullen et al., 2018). Adding questions about e-cigarette use to the NQDW Intake Questionnaire is important so to allow quitlines to assess tobacco product use more accurately among participants and provide cessation services accordingly. This data also can also provide important insight to the tobacco control field about quitting behaviors among people who use e-cigarettes..

Assessing menthol use in the context of cessation is important as studies have suggested that persons who smoke menthol cigarettes have a more difficult time quitting smoking (Trinidad et al 2010; Delnevo et al 2011; Leas et al 2021). The proposed questions are comparable to the optional menthol questions available in the MDS, except that the response categories are aligned with menthol questions that will be implemented as optional modules in the Behavioral Risk Factor Surveillance System (BRFSS) (OMB No. 0920-1061, exp. 12/31/2024). This alignment will allow harmonization of the NDQW data with the population-based BRFSS.

Additionally, adding questions to capture information on participant sexual orientation, gender identity, and military status will support quitline efforts to provide tailored and targeted quitline services to LGBT, military and veteran populations that experience disproportionately high tobacco use (Margolies, 2015; Graham et al., 2011; Klesges et al., 2006; USSD, 2016; Odani et al., 2018). CDC’s proposed sexual orientation and gender identity questions align with comments and recommendations provided by the National LBGT Cancer Network and the North American Quitline Consortium (Attachment A-3).

The four questions proposed for removal from the NQDW Intake Questionnaire are redundant and can be captured through modifications to other exiting questions. For example, the question “Do you have any health insurance, including pre-paid (such as XXX – provide examples for your state) or government programs (such as Medicaid or Medicare)?” is proposed for removal, as the subsequent question, “What type of health insurance do you have?” could capture the same data if the response options were modified to include “currently do not have health insurance.”

As many of the questions are conditional, (e.g. e-cigarette questions are asked only of e-cigarette users), CDC does not expect the net increase to impact burden. In addition, CDC, with contractor assistance from NORC at the University of Chicago, conducted informal testing on response times with the updated questionnaire and findings supported the 10 minute estimate per respondent remaining applicable.

NQDW Services Survey: CDC proposes adding five questions to this instrument: one on availability of services during the reporting period, one on services not captured by the reporting form, one on the provision of tailored cessation protocols for target populations, one on web enrollment, and one on registrations by modality. CDC also proposes minor modifications to 13 questions, either by editing the question text or the response options (NQDW Services Survey – currently questions #2-7, 9, 11-13, and 15-17). Additionally, CDC proposes moving three questions.

The proposed questions regarding which services are available and which services were not captured by the reporting form will allow the NQDW to respond nimbly as new technologies emerge and service modalities are implemented across quitlines (i.e. if text-based intake methods become tenable, CDC can propose a revision to the services survey to proactively gather that information). The proposed question on the provision of tailored protocols for target populations will provide insight into how quitlines are supporting quitting among populations that experience disparities in tobacco product use. This information also will be useful for determining special eligibility criteria for the provision of counseling and medications. Paired with other changes to the NQDW Intake Questionnaire, this item will provide clear insight into the services offered to support quitting among key populations, such as youth and pregnant/postpartum women.

The proposed questions regarding web enrollment, and registrations by modality represent critical new information on shifting modalities in data collection. Though quitlines began as telephone-based services, they have evolved over time to incorporate new technologies and now provide services through additional modalities, such as web and texting services. Adding these questions will enable states to provide a more complete report on all of the services they are providing to quitline participants. This information is vital for both program evaluation and funding justification. Additionally, gathering information on how participants are accessing quitline services is critical for future planning on strategies to leverage emerging technologies to increase quitline reach and effectiveness. Incorporating data on non-phone enrollees not only addresses the terms of clearance of the previous ICR (Reference No: 201903-0920-001), but also supports the collection of information about populations that prefer the use of web and text modalities to phone-based services. Younger generations, for example, are often early adopters of new technologies, and therefore likelier than older adults to not only access a broad range of technologies, but to use those technologies to access health-related information and services (Sanci, 2020; Giovanelli, Ozer, & Dahl, 2020; Wright, 2020; Clarke 2020). Acknowledging the use of new technologies is crucial to ensure complete and accurate data collection efforts.

Because the NQDW Services Survey is presented to states in an electronic form that includes drop-down boxes, data entry fields, and checkboxes to help reduce data entry errors, as well as prepopulated answers to reduce burden, CDC does not anticipate a change in estimated burden for this instrument.

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

Data Tabulation Plans

Data will be tabulated in ways that will address the principal purposes outlined in A.3 (Attachment H). Starting in November 2013, CDC began sharing tabulations using the NQDW data collected publicly online through the CDC’s State Tobacco Activities Tracking and Evaluation (STATE) System website (http://apps.nccd.cdc.gov/statesystem/Default/Default.aspx) which contains a variety of current and historical state-level and national data on tobacco use prevention and control. CDC plans to continue sharing quarterly NQDW data tabulations from the NQDW data on the STATE system on an ongoing basis. Data is reported in aggregate to prevent involuntary disclosure due to small cell sizes at the individual level. Through the CDC’s STATE System, website visitors can access a variety of detailed reports and data tables that present a state-level summary of NQDW data for a single quarter. Detailed reports available on the CDC’s STATE System website that are based upon NQDW data include:

1. Quitline - Services Available

   1. Hours of Operation and Available Languages

   2. Counseling

   3. Medications

2. Quitline – Service Utilization

   1. Call Volume

   2. Services Received

   3. Participant Characteristics

   4. How Participants Heard about Quitline

   5. Types of Tobacco Products Used

CDC STATE System users can also access highlights reports that present state and national trends for several key measures from the NQDW data including quitline call volume, the number of tobacco users who received counseling and/or free quitting medications from quitlines, and the demographic characteristics and tobacco products used by individuals who completed an NQDW Intake Questionnaire. Finally, CDC STATE System users can access maps that present state-level standardized quitline call volume and reach measures. The STATE System is designed to integrate many data sources to provide comprehensive summary data on a state level and facilitate research and consistent data interpretation. The STATE System does not collect data and is simply a way for CDC to display data for public consumption in a user-friendly online environment. Data submitted to CDC for inclusion in the NQDW is cleaned, standardized, formatted, analyzed and shared with states for sign off and verification before being published online.

Publication and Dissemination Plans

CDC has, and continues to, extensively use the information collected by the NQDW for ongoing monitoring and evaluation related to state quitlines. CDC has also relied heavily on data from the NQDW to respond to frequent quitline-related queries from CDC management, the U.S. Department of Health and Human Services (USDHHS), state tobacco control programs, and legislators and policymakers. CDC plans to continue sharing and disseminating NQDW data from this data collection online through the CDC’s STATE System website (http://www.cdc.gov/statesystem) and Tobacco Use Data Portal (https://chronicdata.cdc.gov/browse?category=Tobacco+Use). CDC has also presented findings and results from the NQDW data collection at various meetings and conferences and plans to continue presenting NQDW data at a variety of meetings and conferences.

CDC plans to disseminate NQDW data through several mechanisms that will reach public health providers, clinicians who refer their patients to quitlines, quitline professionals and researchers. For example, data from the NQDW was included in CDC’s Tobacco Control State Highlights 2012 report (CDC, 2013). CDC anticipates presenting NQDW in similar reports in the future. CDC plans to release NQDW data through a variety of government publications, refereed journals, and annual conferences of national organizations focused on tobacco use, prevention and control, preventive medicine, health promotion, and epidemiology. Anticipated publications using NQDW data include:

• Evaluation of the success of CDC’s Tips® national tobacco education media campaigns that CDC has been running annually since 2012 on key quitline outcomes such as call volume and reach

• Profiles of services offered by state quitlines and changes in quitline services offered over time

• Quitline participant characteristics and service utilization among youth quitline service

• Quitline service utilization and reach by tobacco product and select participant population characteristics, United States

• Quitline utilization and treatment reach among people with behavioral health conditions

• Variations in quitline reach and services utilized by insurance type among U.S. adults

• Quitline utilization and reach among people with low social economic status, United States

CDC has already begun several of the analyses described above and plans to continue work on additional topics.

Time Schedule for the Project

The following represents our proposed schedule of activities for the NQDW, in terms of months after receipt of OMB clearance. Data collection is ongoing, and we anticipate obtaining OMB renewals to continue data collection until discontinuation.

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

Activity	Time Period
Ongoing data collection for the NQDW Intake Questionnaire using approved protocols	As soon as possible after OMB approval
Ongoing Seven-Month Follow-up Questionnaire interviews (only for Asian Smokers’ Quitline) using approved protocols	As soon as possible after OMB approval Individuals will be followed-up with 7 months after intake
States/Territories and ASQ submit electronic data files for the NQDW Intake Questionnaire	Quarterly and ongoing
ASQ submits electronic data files for the NQDW Seven-Month Follow-up Questionnaire	Annually and ongoing
States/Territories and ASQ submit NQDW Quitline Services Survey	Semiannually and ongoing
Process data and publish results	Quarterly and ongoing

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

The expiration date of OMB approval of the data collection will be displayed.

A.18 EXCEPTIONS TO CERTIFICATION FOR PAPERWORK REDUCTION ACT SUBMISSIONS

No exemptions from the certification statement are being sought.

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