GenIC application

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-0919)

TITLE OF INFORMATION COLLECTION: English Language Folic Acid Educational Materials: Message Testing and Materials Development

PURPOSE: The purpose of this activity is to examine the response of English speaking women to existing CDC folic acid educational materials. A number of CDC’s English-language folic acid educational materials currently being used were developed over 10 years ago. Research to determine whether these materials continue to be appealing and resonate with the target audience is imperative to the success of our folic acid education efforts. The focus group sessions shall be structured to identify women’s awareness and knowledge about folic acid, and how they would like to see folic acid information portrayed in a written format. This activity is consistent with the national research agenda of CDC’s Division of Birth Defects and Developmental Disabilities.

DESCRIPTION OF RESPONDENTS:

The respondents will be non-pregnant English speaking women, ages 18-44.

TYPE OF COLLECTION: (Check one)

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

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

[X] Focus Group [ ] Other: ______________________

CERTIFICATION:

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:___________Alina Flores [email protected]__________________________________

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

Personally Identifiable Information:

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

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

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

Gifts or Payments:

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

It is proposed that respondents will be given $60 for their participation, effort, transportation and possible childcare costs. This amount is comparable to what has been the level of reimbursement for the target audiences in similar CDC funded activities. Women of childbearing age are often more difficult to recruit than more general audiences because they often have children and need to cover childcare costs to be able to attend the focus group session. Focus group facilities will not offer childcare services due to liability concerns, so the incentive needs to be enough to help the participants cover outside childcare costs if needed. It is assumed that the $60 incentive the women receive for participating in the groups would go toward the transportation costs for many of them to arrive at the facility, as well as the cost for off-site childcare to make it possible for them to attend. Every effort is being made to utilize a focus group facility that is located close to public transportation as well. As shown by the literature referenced below, the payment of incentives can provide significant advantages to the government in terms of direct cost savings and improved data quality.

There have been citations in the literature referencing the importance of monetary compensation for focus group participation. Kruegar (1994) indicates that offering minimal levels of monetary compensation will help ensure that sufficient numbers of participants will attend thereby yielding useful results. Further, in a meta-analysis of 38 experiments and quasi-experiments, Church (1993) found that providing cash incentives for participation was far more effective than nonmonetary gifts in generating survey response, and prepaid monetary incentives yielded an average increase of 19.1 percentage points over comparison groups.  Finally, findings related to the importance of monetary incentives is corroborated in the National Adult Literacy Survey by Berlin (1992) and colleagues (OMB No. 1850-0654, exp. 8/31/1993), and the National Survey of Family Growth.

Offering a monetary incentive at the proposed level will help ensure that respondents honor their commitment of participating in the focus group. Lower incentives could actually result in higher recruiting costs due to the need to over recruit by higher percentages.

BURDEN HOURS

The estimates of annualized burden hours are based on the results of pilot testing, past experience with recruitment, and the administration of similar focus groups. It is estimated that 320 respondents will have to be screened in order to recruit 80 participants. Each screening will take approximately 6 minutes to complete. The estimated response burden for the screening process is 32 hours per project.

A total of 16 focus groups will be conducted. Each focus group will have an average of 4-5 participants. Assuming the larger number of participants (5) in each group, a total of 80 participants will be included. Each focus group will last 1.5 hours. An Informed Consent form will be reviewed with each respondent. The estimated burden for completion of the informed consent form is 6 minutes, for a total burden of 8 hours.

The total estimated burden in hours, including screening and focus group participation, is shown in the table below. Overall, we estimate the total annual burden for participation in this study, to be 160 hours.

Category of Respondent	Form Name	No. of Respondents	Participation Time	Burden
Non-pregnant Women (ages 18-44)	Screener	320	6/60	32
Non-pregnant Women (ages 18-44)	Focus group guide	80	1.5	120
Non-pregnant Women (ages 18-44)	Informed consent	80	6/60	8
Totals				160

FEDERAL COST: The estimated annual cost to the Federal government is _$119,750______

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

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?

Recruitment of Participants

Information for this study will be collected using focus groups with English-speaking non-pregnant women 18-44 years of age who meet the eligibility criteria for the study.

Battelle will conduct all 16 focus groups using a 2-person team consisting of two experienced qualitative researchers. One person will serve as the moderator and will be responsible for reviewing the consent form and asking questions using the moderator’s guide. The second person, the co-moderator, will serve as the assistant and will take detailed notes. All interviews will be audiotaped and transcribed by a professional transcriptionist at a later date. Each focus group will last approximately 1.5 hours and light refreshments will be provided.

The focus group moderator’s guide will be followed to ensure that all of the important topics are addressed in each group. Focus group topic development was based on the study aims and on our review of recent literature concerning food fortification and other complex health conditions.

Discussion topics will include topics on awareness, knowledge of healthy diets, vitamin intake, and folic acid. Additionally, participants will be shown a few educational brochures about folic acid and birth defects. They will be asked about their opinions on the message, layout, design, color, and length of each brochure.

Recruitment will be conducted in Atlanta and St. Louis. These two cities were selected primarily for convenience and to reduce travel costs for project staff -- Battelle has offices in both cities and CDC has offices in Atlanta. The target audience for this project is broad and can readily be found in these cities.

Battelle will subcontract with experienced, reputable focus group facilities and recruiting services providers in the two study sites to conduct screening and recruiting of participants. These subcontractors have up-to-date databases with demographic information including gender, country of origin, race/ethnicity to help them identify potential focus group participants. Contact information of potentially eligible participants will be drawn from these databases based on age (18-44 years old) and gender (female). Whenever potential participants refuse to participate, the subcontractor will draw more names from the database of other potential participants. The day prior to the focus groups, the subcontractors will call each women who have agreed to participate to remind her about the attending the focus group. Because we are conducting ‘mini-groups’, we expect to have 4-5 participants per group.

Purposive sampling is a non-probability sampling technique used in qualitative research. This type of sampling permits the selection of interviewees whose qualities or experiences permit an understanding of the phenomena in question, and are therefore valuable. We will use a purposive sampling technique to select participants for this project. Inclusion criteria are: being female, age 18 to 44 of age, English-speaker, not pregnant at the time of the focus groups, and have not had children with the birth defects spina bifida or anencephaly.

Administration of the Instrument

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

[ ] Web-based or other forms of Social Media

[ ] Telephone

[ X] In-person

[ ] Mail

[ ] Other, Explain

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

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

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g. Comment card for soliciting feedback on xxxx)

PURPOSE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

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.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: 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.

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)

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

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

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.

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.

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

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