GenIC Request Template

GenICRequestTemplate_PPE Distribution_H5N1 Outbreak-PRArev_final.docx

[OS] CDC/ATSDR Formative Research and Tool Development

GenIC Request Template

OMB: 0920-1154

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Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

Shape1 CIO: Office of Readiness and Response

PROJECT TITLE: Successes of and Barriers to Distribution of PPE During the 2024 Dairy Cattle H5N1 Outbreak

PURPOSE AND USE OF COLLECTION: In March 2024, avian influenza A(H5N1) was confirmed in dairy cattle on a Texas dairy farm. On April 5, 2024, CDC issued a Health Alert Network notice indicating the spread of avian influenza A(H5N1) to a human dairy worker, likely linked to exposure to an infected cow. Since then, numerous herds of dairy cattle and multiple human cases linked to dairy farms have been detected across the U.S. On May 6, 2024, CDC requested that health departments (HDs) work with state agriculture colleagues to make personal protective equipment (PPE) available to dairy farm, poultry farm, and slaughterhouse workers. CDC requested a prioritized distribution of PPE, first to farms with known positive or presumptive positive herds with avian influenza A(H5N1), then to states that have submitted samples for pre-movement PCR testing, and then to farms with no evidence of positive herds or any tests awaiting results.

We propose a mixed-method evaluation of the distribution of PPE among dairy farm workers following CDC’s May 6, 2024, request. The results of this project may help shape the ask of HDs and will help CDC’s NIOSH to understand the employer perspective and specific types of requested PPE. This could ultimately help inform messaging of the importance of specific PPE and future requests.



DESCRIPTION OF RESPONDENTS: Included in the project for data collection will be directors of public health preparedness, with inputs from state public health veterinarians and state animal health officials, and any other involved staff.



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: _Lara Misegades_______________________________________________

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 [ ] 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

Key informant interview (State Public Health Emergency Preparedness Directors, State Animal Health Officials, State Public Health Veterinarians)

Key Informant Interview Questionnaire

15

45 minutes

11 hours

Survey (State Public Health Emergency Preparedness Directors (PHEP), with inputs from State Animal Health Officials (SAHO), State Public Health Veterinarians (SPHV) and other relevant staff)

Online Survey Questionnaire

50

120

100 hours

Totals




111 hours



FEDERAL COST: The estimated annual cost to the Federal government is $54,091



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?

  1. Key informant interviews (KII)

Population: All state HDs.


Sample: Sample of key informants from state health departments, including State Public Health Emergency Preparedness Directors (PHEP), State Animal Health Officials (SAHO), and State Public Health Veterinarians (SPHV). The sample will include states with known positive or presumptive positive herds with avian influenza A(H5N1), as well as states with no evidence of positive herds.


  1. Online Survey

Population: All state HDs.


Sample: State health departments (Directors of public health preparedness (DPHPs), state public health veterinarians and state animal health officials in all 50 U.S. States (TBD: District of Columbia, Territories and Tribal Nations).




Administration of the Instrument

  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

Instruments will be pre-tested in the form of discussions with select state health department representatives, including State Public Health Emergency Preparedness Directors (PHEP), State Animal Health Officials (SAHO), State Public Health Veterinarians (SPHV).

Key informant interviews will be done first, which will inform any modifications to the draft online survey administered to state health department representatives, including State Public Health Emergency Preparedness Directors (PHEP), State Animal Health Officials (SAHO), State Public Health Veterinarians (SPHV).

Online survey of state health departments including State Public Health Emergency Preparedness Directors (PHEP), State Animal Health Officials (SAHO), State Public Health Veterinarians (SPHV).



  1. 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



Shape2 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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