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: FDA CTP Exchange Lab Syndication Study — Current Users

1. PURPOSE: This proposed study will request information to improve the FDA.gov Center for Tobacco Products (CTP) content syndication services provided through the CTP Exchange Lab website (https://digitalmedia.hhs.gov/tobacco/). Content syndication is a method by which digital content (e.g., text, infographics) is made available to other websites, blogs, and other digital channels. Currently, little is known about the syndication subscribers in Exchange Lab and what their content needs are. FDA is seeking to conduct research to learn more about current CTP Exchange Lab users and how satisfied they are with the content syndication service that is offered through the Exchange Lab website.

2. DESCRIPTION OF RESPONDENTS: The study will consist of up to 175 Exchange Lab subscribers with syndication feeds. These users have opted in, voluntarily, to be included in the database by registering through the CTP website page, Center for Tobacco Products Exchange Lab: FDA’s Tobacco Education Resources (https://digitalmedia.hhs.gov/tobacco). To be eligible to participate in the online survey for the FDA CTP Exchange Lab Syndication: Current Users Study, each respondent must:

• Currently subscribe to the CTP Exchange Lab and use the syndication feed.

• Be 18 years of age or older (as determined by a screener question on the survey).

• Have access to the internet.

• Not be an employee or a contractor working for CTP.

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:

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.

Contact Name: Atanaska (Nasi) Dineva, MS

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?

[ X ] Yes [ ] No

The CTP research team will not collect any personally identifiable information (PII) from survey respondents (such as respondents’ mailing addresses or social security numbers). However, for those respondents who are interested in receiving the $5 e-gift card incentive, or in being considered to participate in a future online usability test session of the CTP Exchange Lab, they will be asked to provide their name and email so that CTP can send them the $5 e-gift card or contact them in the future, accordingly.

The PII collected for the purpose of distributing the incentive will be handled differently than the PII handled for contacting participants for a subsequent, future study. Each set of PII (incentives versus subsequent study) will be kept in separate and private (password protected) storage files. Only study team members who are directly involved with the research study will have access to the aggregated data and the separate file that has the names and email addresses of participants who agreed to future contact.

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974?

[ ] Yes [ X ] 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?

[X] Yes [] No

CTP will be offering a $5 e-gift card to survey respondents as a token of appreciation. The potential pool of respondents for this survey consists of 175 individuals – those who have created content syndication feeds on the Exchange Lab website. Obtaining feedback from this group of participants is important as their experience with the Exchange Lab syndication tool can help CTP improve the content syndication service it provides. Because the potential pool of respondents for this survey is so small (175 current users), CTP would like to offer a $5 gift card as a token of appreciation to participants to encourage participation and obtain a response rate of at least 30%. Without a token of appreciation, we anticipate that participation in the survey will be low. In the past, CTP has conducted similar surveys with other types of CTP subscribers, which did not offer a token of appreciation; these surveys had response rates of 0.83% and 0.88% (FDA CTP Email Communications Surveys – 2017 and 2018).

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		Number of Respondents	Participation Time	Burden (rounded)
Exchange Lab Subscriber	Review email invitation to take survey, and click on survey link/Review email reminder (if necessary)	175	2 minutes	6
	Review informed consent form and agree to take the anonymous survey voluntarily	175	5 minutes	15
	Take survey	175	9 minutes	26
Total Annualized Hours				47

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 FDA is not conducting a focus group, survey, or is not planning to employ statistical methods.

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?

[ ] Yes [X] 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?

A list of Exchange Lab registrants, who have created content syndication feeds, will make up those who will be asked if they would like to volunteer as participants. Any of those individuals may participate in the survey. As such, there is no sampling plan but rather the whole population available for surveying will be invited to participate.

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

The information will be collected through a one-time, self-administered online survey. The survey includes 19 questions, including four multipart questions. Except for two open-ended questions, the survey questions include closed-ended response categories where the respondent must select one of various options. For the multipart questions, respondents who answer a specific way on one question will receive other specific questions afterwards.

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

REQUESTED APPROVAL DATE: June 21, 2019

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst: Ila S. Mizrachi

301-796-7726

[email protected]

Program Contact: Janine Delahanty

240-402-9705

Janine [email protected]

FDA CENTER: Center for Tobacco Products (FDA/CTP)

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