Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: NCEZID

PROJECT TITLE: Formative Research to Support Active Surveillance of Myalgic Encelphalomyelitis/Chronic Fatigue Syndrome Among Schoolchildren

PURPOSE AND USE OF COLLECTION:

The purpose of this GEN-IC is to field test an approach for surveillance of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) by building on and improving ongoing active surveillance of chronic conditions associated with absenteeism and school withdrawal among US schoolchildren. The data from the proposed GEN-IC will be used 1) to fine-tune a new electronic data collection tool and active surveillance methods for school-level surveillance of chronic conditions, including ME/CFS; 2) to enhance technical assistance and training to support this surveillance activity; 3) to identify considerations for scaling up the piloted approach.

DESCRIPTION OF RESPONDENTS:

Respondents for the proposed data collection will be from U.S. school districts in states where physicians experienced in caring for patients with ME/CFS practice. School districts have been chosen to include urban, suburban, and rural areas. The respondents will be school nurses in the selected school districts, who will test the new data collection tool and describe their needs and experiences related to this activity; administrators in the same school districts, who will describe the impact of the activity on their district; and school data coordinators in all fifty states, who will report on training and technical assistance needs relevant to school surveillance of chronic health conditions, including ME/CFS.

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: ____Jeanne Bertolli____________________________________________

To assist review, please answer the following questions:

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 [X ] 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? [ ] Yes [ X ] No

BURDEN HOURS

Category of Respondent	Form Name	No. of Respondents	Participation Time (minutes)	Burden in Hours
Frontline School Nurse	Electronic Platform Quarterly Chronic Absenteeism Data Reporting Form	6	300	150
Frontline School Nurse	Demographic Data Collection Points	6	360	36
Frontline School Nurse	Pilot Site Baseline Survey	6	10	1
State Data Coordinators	Webinar 1 Feedback Form	50	15	12.5
Frontline School Nurse	Question Guide for Face to Face Evaluation Interviews	6	90	27
School District Representative	School District Feedback Form	6	15	1.5
Totals				228

FEDERAL COST: The estimated annual cost to the Federal government is ___$193,980______

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?

Administration of the Instrument

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

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

[x ] Telephone

[x ] 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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