OMB approval memo

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

A. TITLE OF INFORMATION COLLECTION: 2021 Center for Veterinary Medicine (CVM) Environmental Scan

1. PURPOSE:
   
   Every 2-3 years CVM conducts an Environmental Scan to gather information and identify major trends in CVM’s internal and external environments in order to support, inform, and improve long-term and short-term strategic planning. Feedback is requested from vital stakeholders to provide insight on forces outside of CVM’s boundaries that are helping to shape our organization. This will provide an external perspective necessary for us to capitalize on identified strengths, address our weaknesses, and keep pace with emerging trends. The feedback received will be summarized in a final report to Center leadership to help inform strategic planning.
   
   

2. DESCRIPTION OF RESPONDENTS:
   
   Respondents represent key organizations that CVM interacts with routinely, as well as those that are in the position to understand the Center’s mission and responsibilities. These stakeholders include regulated industry whose products and services affect animal and human health.
   
   

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 [ X] Customer Satisfaction Survey

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

[ ] Focus Group [ ] Other: ______________________

4. 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:

The collection is voluntary.

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

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

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

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

5. 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: Keira Boyce

Office of Management

Center for Veterinary Medicine

240-402-0717

[email protected]

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

5. 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

6. 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)

7. 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
CVM Industry Stakeholders	30	30 min.	15
Federal Partners	6	30 min.	3
Totals	36		18

8. FEDERAL COST:

The estimated annual cost to the Federal government is $0.

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?

Targeted respondents include key CVM stakeholders that the Center interacts with on a regular basis. These stakeholders include our federal partners as well as regulated industry whose products and services affect animal and human health. Please see attached list.

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)
   
   

[ ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ X ] Other, Explain (Email)

2. 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: March, 2021

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

[email protected]

301-796-7726

Keira Boyce

[email protected]

240-402-0717

FDA CENTER: Center for Veterinary Medicine

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