FDA CTP Industry Public Meeting Study

Appendix B. Food and Drug Administration (FDA) Center for Tobacco Products (CTP)

Industry Public Meeting Study Instrument

Note: The survey respondent will not see any text in blue.

The purpose of this survey for manufacturers and importers is to learn about you and your company’s information needs regarding the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) rules, regulations, policies, and guidances. The results of this study will be used to improve the usability of the CTP website on FDA.gov. Would you like to participate in this study?

1. Yes

2. No [TERMINATE SURVEY; GO TO TERMINATION TEXT 1]

3. Prefer not to answer [TERMINATE SURVEY; GO TO TERMINATION TEXT 1]

[TERMINATION TEXT 1:] Based on your answer, you do not qualify for this survey. Thank you very much for your time.

[INSERT APPENDIX D, INFORMED CONSENT HERE]

We would like to thank you for participating in the survey. The following questions will be about you, your company, and if you use the CTP website on FDA.gov.

1. What year were you born?

[Drop-down menu]

[TERMINATE SURVEY AND GO TO TERMINATION TEXT 1 IF RESPONDENT WAS BORN IN 1999 OR LATER]

2. Do you work for a company involved in the manufacture or import of tobacco products (e.g., cigarettes, e-cigarettes/vapes, cigars, smokeless tobacco products, hookah tobacco, pipe tobacco, roll-your-own tobacco?)

1. Yes

2. No [TERMINATE SURVEY; GO TO TERMINATION TEXT 1]

3. Prefer not to answer [TERMINATE SURVEY; GO TO TERMINATION TEXT 1]

3. Which tobacco product or products does your company manufacture or import? [SELECT ALL THAT APPLY.]

1. Cigarettes

2. Cigars

3. Dissolvables

4. Electronic Nicotine Delivery Systems, such as e-cigarettes, vapes, vaporizers, e-liquids, etc.

5. Hookah (Waterpipe) Tobacco

6. Nicotine Gels

7. Pipe Tobacco

8. Roll-Your-Own Tobacco

9. Smokeless Tobacco, including dip, snuff, snus, and chewing tobacco.

10. Prefer not to answer

4. What role do you have at your company?

[Open-ended text box]

5. From very small to very large how large would you consider your tobacco company, firm, or organization compared to the average company in your industry?

1. Very small compared to industry average

2. Somewhat small compared to industry average

3. Average

4. Somewhat large compared to industry average

5. Very large compared to industry average

6. I do not know

7. Prefer not to answer

6. How many people work for your tobacco company, firm, or organization?

1. 0-49

2. 50-100

3. 101-150

4. 151-200

5. 201-250

6. 251-300

7. 300+

8. I do not know

9. Prefer not to answer

7. How do you learn about the FDA requirements for your product? [SELECT ALL THAT APPLY.]

1. The FDA.gov CTP website

   1. How satisfied or dissatisfied are you with the FDA.gov CTP website? [This follow-up question will only appear if the respondent checks “The FDA.gov CTP website”]

      1. Very satisfied

      2. Somewhat satisfied

      3. Neutral (neither dissatisfied or satisfied)

      4. Somewhat dissatisfied

      5. Very dissatisfied

      6. Prefer not to answer

   2. Please feel free here to make suggestions for how we can improve our the FDA.gov CTP website. [This follow-up question will only appear if the respondent checks “The FDA.gov CTP website”] [open-ended text box]

2. Industry publications or websites (digital or in print)

   1. Which industry publications do you read to learn about the FDA requirements for your product? [SELECT ALL THAT APPLY.] [This follow-up question will only appear if the respondent checks “Industry publications”]

      1. Tobacco Reporter

      2. Tobacco Journal International

      3. Tobacco Products International

      4. Smokeshop

      5. Tobacco International

      6. Smoke

      7. Eurotab

      8. Tobacco Business Magazine

      9. Other; Please specify: __________ [open-ended text box]

      10. Prefer not to answer

3. @FDATobacco on Twitter

4. CTP Emails

5. Online search, such as Google

6. Other [open-ended text box]

7. Prefer not to answer

8. Which of the following FDA application processes would you need to complete to market your product(s)? [SELECT ALL THAT APPLY]

1. Substantial Equivalence (SE) Application

2. Exemption from SE Application

3. Pre-Market Tobacco Application (PMTA)

4. Modified Risk Tobacco Product (MRTP) Application

5. Tobacco Product Master Files (TPMF) Application

6. Grandfathered Status

8. Not Sure.

   1. Please indicate why you are not sure. [This follow-up question will only appear if the respondent checks “Not Sure”] [open-ended text box]

9. Prefer not to answer

9. Are you interested in participating in an online usability test session at a later date? This test session will be conducted remotely (online) and the information will be used to help improve CTP’s website. Participants will receive compensation for the completion of this session.

1. Yes

   1. Please provide your contact information so that we may contact you. [This follow-up question will only appear if the respondent checks “Yes”]

      1. Name [open-ended text box]

      2. Email [open-ended text box]

2. No

Thank you very much for taking the time to complete our Industry Survey!

The FDA CTP Team

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 5 minutes per response (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to [email protected].

[End of survey]

OMB#: 0910-0697 | Exp. 12/31/20

RIHSC #18-058CTP

Rev. 9/18/2018