FDA Tobacco Regulatory Requirement Information Survey

OMB No. X

FDA Tobacco Regulatory Requirement Information Survey
Telephone Interview Protocol

Interviewer

Hello, My name is X and I am calling on behalf of the FDA Center for Tobacco Products (CTP) to gather input from stakeholders that partner with FDA or that are impacted by FDA requirements for tobacco. Your participation is completely voluntary and your responses will not have an effect on your future interactions or dealings with the FDA.  Moreover, this survey fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.

This interview should take approximately 10 minutes. The primary focus of the interview questions is to assess the interviewee’s comfort and understanding of the processes and availability and accessibility of materials pertaining to procedures and processes related to FDA’s tobacco program and requirements. A secondary component of this interview is to understand how effective the material is in conveying how to interact and engage with CTP staff.

Let’s begin

1. Are you aware of that the FDA now regulates the manufacturing, advertising, distribution, and sale of certain tobacco products?
   
   

2. Are you familiar with the procedures for engaging and interacting with FDA on tobacco requirements and issues of importance to you?

3. How have you developed the knowledge of the FDA and procedures for engaging with the FDA?

Let me know each area that has been useful to you in acquiring knowledge about FDA and how to engage with the agency on tobacco regulations.

• FDA website

• Mailed materials from FDA

• Previous interactions with FDA

• Webinar presentation

• One-to-one training from the State Program Coordinator or other official

• On-the-job training or coaching

• Other–Describe:

4. What non-FDA materials are available to you to help explain how to work with the FDA in their implementation of the Tobacco Control Act?

5. Where are these non-FDA materials from?

• Website

• Mailed materials

• Webinar presentation

• One-to-one training from the State Program Coordinator or other official

• On-the-job training or coaching

• Other–Describe

6. What aspect of the tobacco control act is most difficult to learn and understand? What additional information would be helpful?

7. Using a scale from 1 to 5, with 5 being most effective and 1 being least effective, Please rate the effectiveness of the current materials developed by FDA that explain the procedures and processes.

   • Website

   • Mailed Materials

   • Webinar presentation

   • One to one training

   • On the job training

   • Other - describe

8. How can procedures and processes at CTP be improved so that stakeholders can better engage with FDA on the FDA’s tobacco program and requirements? Please be specific about which procedures and/or processes you are evaluating.

9. Do you have any suggestions on how the existing materials could be improved or what additional materials are needed?

10. What form of learning medium(s) is most effective for you (please select all that apply):

• Web based learning

• Classroom based learning

• Video based learning

• Internet sites

• Fact sheets

• Job aids

• One-on-one mentoring

• Paper-based training materials

• Other

The interview is now complete. On behalf of the Center for Tobacco Products, I want to thank you for your time today.

DRAFT 2/8/12 3