OMB Approval Memo

0697 OMB Approval Memo - Use of Pentobarbital Among Veterinarians 2020.docx

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

OMB Approval Memo

OMB: 0910-0697

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Request for Approval under the “Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery”
(OMB Control Number: 0910-0697)

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A. TITLE OF INFORMATION COLLECTION:
Survey to Determine Euthanasia Practices and Use of Pentobarbital Among Veterinarians Practicing in the United States


  1. PURPOSE:

    A quantitative survey of the American Veterinary Medical Association (AVMA) members will be conducted to gauge veterinary practitioner understanding of euthanasia methods, and to gather information about how veterinarians choose euthanasia method by species, and recommendations veterinarians make for disposal of the resulting carcass. This survey is being conducted as a part of a contract (Contract No. 75F40120P00437) awarded to International Consulting Associates (ICA) who has subcontracted with AVMA to perform the survey of their members. The survey results will be used as part of a final project report for the contract to help inform communication and outreach by FDA CVM to veterinarians regarding pentobarbital use and carcass disposal.

  2. DESCRIPTION OF RESPONDENTS:

    The respondents will be veterinarians who are also members of the American Veterinary Medical Association.

  3. TYPE OF COLLECTION: (Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.)


[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[ ] Focus Group [X] Other: _Online survey___


  1. CERTIFICATION: Please read the certification carefully. If you incorrectly certify, OMB will return the generic as improperly submitted or it will be disapproved.


I certify the following to be true:

  1. The collection is voluntary.

  2. The collection is low-burden for respondents and low-cost for the Federal Government.

  3. The collection is non-controversial and does not raise issues of concern to other Federal Agencies.

  4. The results are not intended to be disseminated to the public.

  5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

  6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.


Name: Emily Cornwell

Office of Surveillance and Compliance

Center for Veterinary Medicine

301-837-7541

[email protected]


To assist review, please provide answers to the following question:


  1. PERSONALLY IDENTIFIABLE INFORMATION (PII): Provide answers to the questions. Note: Agencies should only collect PII to the extent necessary, and they should only retain PII for the period of time that is necessary to achieve a specific objective.

  1. Is personally identifiable information (PII) collected? [ ] Yes [X] No

  2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

  3. If Yes, has an up-to-date System of Records Notice (SORN) been published? [ ] Yes [ ] No


  1. GIFTS OR PAYMENT: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] No


BURDEN HOURS: Identify who you expect the respondents to be in terms of the following categories:

(1) Individuals or Households;
(2) Private Sector;
(3) State, local, or tribal governments; or
(4) Federal Government.

Only one type of respondent can be selected per row.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group)


  1. BURDEN: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.


Category of Respondent

No. of Respondents

Participation Time

Burden

Individuals or Households

3,337

10 min

557


  1. FEDERAL COST: There is NO estimated annual cost to the Federal government.


B. STATISTICAL METHODS

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:


The selection of your targeted respondents: Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.


  1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe?


[X] Yes [ ] No


If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?


The AVMA proposes to conduct a voluntary quantitative survey of a small subset (3,337) of 96,000 members to gauge practitioner understanding of euthanasia methods, and gathering information about decision-making considerations for choice of euthanasia method by species, and recommendations made (or not) for disposal of the resulting carcass. This is described more fully in the attached draft of the survey instrument, which lays out the sampling plan.


Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.


  1. How will you collect the information? (Check all that apply)

[X] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain


  1. Will interviewers or facilitators be used? [ ] Yes [X] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.



REQUESTED APPROVAL DATE: January, 2021.


NAME OF PRA ANALYST & PROGRAM CONTACT:


Ila S. Mizrachi

[email protected]

301-796-7726


Emily Cornwell, DVM, PhD.

Office of Surveillance and Compliance

[email protected]

301-827-7541


FDA CENTER: Center for Veterinary Medicine (FDA/CVM)

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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleDOCUMENTATION FOR THE GENERIC CLEARANCE
Author558022
File Modified0000-00-00
File Created2021-01-19

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