GenIC Request Template

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: National Center for Emerging and Zoonotic Infectious Diseases

PROJECT TITLE: Focus Groups with Infectious Disease Physicians and Pharmacists on Antifungal Therapeutic Drug Monitoring

PURPOSE AND USE OF COLLECTION: The Centers for Disease Control and Prevention (CDC) is requesting approval for a new generic information collection (gen-IC). The goals of this evaluation are to assess knowledge, perceptions, experiences, and barriers to antifungal therapeutic drug monitoring (TDM), in order to inform future communications efforts to increase awareness of antifungal TDM, address knowledge gaps and barriers to the practice, and improve antifungal TDM adherence.

DESCRIPTION OF RESPONDENTS: Infectious disease physicians and hospital or infectious disease pharmacists.

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. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

Name: Mike Ruddell, Vice President, KRC Research

To assist review, please answer the following questions:

Personally Identifiable Information:

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

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

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

Gifts or Payments:

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

Focus group participants will receive a monetary incentive of $75 for their participation. Such an incentive is a standard practice in the market research industry and helps to ensure efficient recruitment and ultimate participation among the qualified and scheduled participants. The incentive is also intended to offset the cost of personal or professional time taken to participate.

BURDEN HOURS

Type of Respondent (All Private Sector)	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden Per Response (hours)	Total Burden Hours
ID Physicians	Screener	160	1	5/60	13
	Focus Group Guide (FG participation)	16	1	1.5	24
ID and Hospital Pharmacists	Screener	80	1	5/60	7
	Focus Group Guide (FG participation)	8	1	1.5	12
Total					56

FEDERAL COST: The estimated annual cost to the Federal government is $94,641.

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? [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?

Potential participants are drawn from a national panel of individuals who have opted in to participate in focus groups on various topics. The contractor KRC Research will direct a vendor panel provider to distribute an invitation to screen for the focus groups to members of its panel, starting with those individuals whose panel profiles suggest they are most likely to qualify (e.g., known to be physicians or NPs or PAs, have known specialties). When an individual receives the invitation to screen, they will either complete a screening questionnaire online (Attachment 1) or via the phone in a call with a panel provider staff member. Individuals must pass the screening questionnaire without being disqualified based on their answers or due to quotas reached on certain characteristics.

Eight participants will be purposively selected from this pool of eligible participants for each of three focus groups, for a total of 24 participants. Within the parameters of physician and pharmacist audience, participants will be selected to maximize variability across practice settings, geographic region, age, sex, and race and ethnicity.

Administration of the Instrument

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

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

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

Instructions for completing genIC Request for Approval for

CDC/ATSDR Formative Research and Tool Development

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is requested.

PURPOSE and USE: 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: Briefly describe the targeted group/groups for this collection.

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.

Form: Provide the title of the information collection form.

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 in Minutes: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

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.

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