Form 1 ODS Interview Guide for AMRA Stakeholders

Analytical Methods and Research Materials (AMRM) Program

Stakeholder Interviewer Guide

Participant Name: ___________________________________

Organization: ___________________________________

Contact telephone: ___________________________________

Agreed to participate: Yes No

If yes, provide agreed upon time: _________________________________

To be read at start of interview:

Thank you for agreeing to participate in the Office of Dietary Supplement’s Analytical Methods and Research Materials (AMRM) Program’s stakeholder feedback interview process. The AMRM program’s purpose is to assist a target audience of industry, researchers, and regulators through the development, validation, and dissemination of analytical approaches for the quantification and identification of dietary supplement ingredients and products. As part of the program’s five-year review, key stakeholders in the dietary supplement community are being asked to participate in this brief interview to gather feedback about the AMRM Program’s key program areas, structure and implementation.

Your feedback is important to us. Your responses will be summarized and presented in a comprehensive report to an expert panel for the purpose of recommending program improvements. We will not retain any personally identifiable information and all responses are combined for reporting purposes. No one response will be attributed to any one person. We estimate that this interview will last approximately 20 minutes. Thank you for your time.

[This page is for planning purposes only, not to be included in the interview records retained and analyzed.]

OMB # 0925-0648

Expiration Date 03/2018

Public reporting for this collection of information is estimated at 20 minutes per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.

AMRM Program Stakeholder Feedback Interview Instrument

1. Respondent’s Background

1. What is your role at your organization with respect to the area of dietary supplements?

2. How is your organization involved with the Analytical Methods and Reference Materials (AMRM) Program?

3. Does your organization use any of the analytical methods that were developed as part of the AMRM Program?

   1. Yes

   2. No

4. Does your organization use any of the reference materials that were developed as part of the AMRM Program?

   1. Yes

   2. No

5. Does your organization use any of the other resources supported by the AMRM Program (i.e., research funding, the laboratory quality assurance program, or the publishing of method validation guidelines and reference books on botanical safety and microscopic characterization)?

   1. Yes

   2. No

2. Feedback on AMRM Program

Now I would like to ask you to provide some feedback on specific AMRM Program areas.

On a scale from 1 to 5, please state how valuable each AMRM program area is to your organization’s mission and indicate your level of satisfaction with it (5 is very valuable or satisfied and 1 is not valuable/satisfied).

6. Analytical method validation and publication;

Value: 5----------4----------3----------2----------1

Satisfaction: 5----------4----------3----------2----------1

Please provide any specific feedback: ___________________________

7. Certified reference material development and availability;

Value: 5----------4----------3----------2----------1

Satisfaction: 5----------4----------3----------2----------1

Please provide any specific feedback: ___________________________

8. Support of partnerships between the public and private sectors which enhance chemical and biological characterization of dietary supplements;

Value: 5----------4----------3----------2----------1

Satisfaction: 5----------4----------3----------2----------1

Please provide any specific feedback: ___________________________

9. Dissemination of information related to method and material development;

Value: 5----------4----------3----------2----------1

Satisfaction: 5----------4----------3----------2----------1

Please provide any specific feedback: ___________________________

Now, I would like to ask you to provide some feedback on specific ways in which the AMRM Program is structured and implemented.

Again using a scale from 1 to 5, please tell me how effective the administrative and organizational processes of the AMRM Program have been with the following tasks. (5 is completely effective and 1 is ineffective). Please provide additional comments to explain you answer.

10. Identifying the most important methodology and reference material needs of the dietary supplement community

Effectiveness: 5----------4----------3----------2----------1

Comment: ___________________________________

11. Prioritizing the methodology and reference material needs of the dietary supplement community

Effectiveness: 5----------4----------3----------2----------1

Comment: ___________________________________

12. Engaging with the appropriate dietary supplement stakeholders and scientific experts

Effectiveness: 5----------4----------3----------2----------1

Comment: ___________________________________

13. Facilitating the involvement of your organization in the validation of methods and development of reference materials

Effectiveness: 5----------4----------3----------2----------1

Comment: ___________________________________

14. Accelerating the validation of analytical methods and the development of reference materials

Effectiveness: 5----------4----------3----------2----------1

Comment: ___________________________________

To end our discussion, I would like to ask you a general question about your experiences with the AMRM Program.

15. What are the AMRM Program’s strengths or weaknesses with respect to your organization obtaining or using AMRM-supported reference materials or methods?

16. Before we finish, is there anything else you would like to add?

Thank you for taking time out of your busy schedule to meet with us today. We really appreciate your comments and suggestions regarding the AMRM Program.

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