Supporting Statement A

State, Territorial, and Local Health Department Preparedness for Persons Under Investigation for Ebola Virus Disease

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

SUPPORTING STATEMENT – Section A

Submitted: 10/3/2014

Program Official/Project Officer

Michelle Chevalier and Charnetta Smith

Epidemic Intelligence Service (EIS) Officers

Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention

1600 Clifton Road, NE, Mailstop D18, Atlanta, GA 30333

404-553-7582

[email protected] (Michelle Chevalier) and [email protected] (Charnetta Smith)

Section A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

Background

This information collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2) – OMB No. 0920-0879. The respondent universe for this information collection aligns with that of O2C2. Data will be collected from: 55 state, territorial and local health departments lead epidemiologists (50 states, District of Columbia, 1 territory (Puerto Rico) and 3 cities (NYC, Chicago, Los Angeles) or designated as other titles such as health scientists, or medical officers acting in their official capacities.

This information collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241). This information collection falls under the essential public health service of (1) to enforce laws and regulations that protect health and (2) to ensure assure a competent public and personal health care workforce.

The 2014 Ebola epidemic is the largest Ebola outbreak in history and the first one to occur in West Africa (CDC¹).  With its first cases reported on March 22^nd, 2014, initially this epidemic was isolated to Guinea with 49 cases². As of September 2014, this West African Ebola epidemic has spread to Sierra Leone, Liberia, Nigeria, and Senegal, with approximately 6000 confirmed, probable, and suspected cases and over 2800 deaths; including over 300 healthcare worker (HCW) cases, and over 200 HCW deaths—a 60% case fatality rate³ . Despite international humanitarian and prevention efforts, Ebola transmission continues in all affected countries except Nigeria. As of September 2014, the country of Nigeria has been able to effectively halt the spread of Ebola, and this was in large part due to their level of preparedness.

Preparedness for the management of individuals exposed to Ebola encompasses multiple tasks.  Among many things, state health departments have to be able to effectively and efficiently identify potential patients with the use of vigorous screening protocols.  Once identified, the health care system has to have procedures in place for the safe handling of specimens, the disposal of medical waste, the safe provision of medical care, and the surveillance of contacts.  In so doing, these techniques must also be able to prevent viral spread to healthcare personnel and unaffected individuals in the general population.

As of September 2014, over 119 CDC employees are currently deployed to affected nations, 123 individuals have completed deployment, and since July 9^th, 2014 over 860 CDC staff have provided logistical, epidemiological, laboratory, and infection control response and support in the Emergency Operation Center (EOC) in Atlanta⁴ . In the EOC, the Ebola Response Epidemiology team has been tasked with the duty to triage and manage clinical inquiries about the handling of individuals in the U.S. with potential Ebola exposures.  The majority of these clinical inquiries have come from state health departments and they encompass a host of issues from clinical questions to waste management. Given the topical breadth of these inquiries, it is become evident that there is a need for a better understanding of how prepared state health departments are for managing persons with Ebola exposures.

The first U.S. clinical inquiry about an individual with a possible Ebola exposure—also known as a Person Under Investigation or PUI—was received by our team was on July 28, 2014.  Since then, there have been over 90 other inquiries. Overall, a PUI is defined as the following: a person who has presented to a U.S. health care setting for medical evaluation, with some perceived risk factor for Ebola and whose case has been brought to the attention of the state health department and/or CDC.  These risk factors include but are not limited to: recent travel to an affected country (Guinea, Liberia, Sierra Leone, Democratic Republic of Congo, Nigeria, or Senegal), with or without an exposure to someone with confirmed or suspected EVD, and with symptoms of Ebola. 

To date, we estimate that there are a host of PUI inquiries that get triaged at the state/local level that are never brought to the attention of CDC.  To this end, the purpose of this assessment is to quantify the total number of domestic inquiries since the beginning of the outbreak, to assess the level of preparedness of state health departments, and to identify areas for future improvement.

Privacy Impact Assessment

Overview of the Data Collection System

The information collection system consists of a web-based questionnaire (see Attachment A: Data collection instrument, MS Word version and Attachment B: Data collection, web version) designed to assess what type of readiness activities the state health departments have in place to manage potential EVD patients. The information collection instrument will be administered as a web-based instrument. The information collection instrument was pilot tested by four public health professionals for burden, reliability, and validity. Feedback from this group was used to refine questions as needed, ensure accurate programming and skip patterns and to establish the estimated time required to complete the information collection instrument.

Items of Information to be Collected

The data collection instrument consists of 18 questions, some multiple choice and some open-ended. The assessment questions each pertain to U.S. domestic inquiries and preparedness to manage them.

• Quantitative Data on PUIs

• Qualitative Data on PUIs

• Information Sharing/Data flow

• PUI Surveillance

• EVD Preparedness

  • Training Protocols

  • Usage of CDC Guidance Documents

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

No website content will be directed at children.

2. Purpose and Use of the Information Collection

The purpose of the information collection is to assess the status of PUI inquiries in the U.S. over time since the start of the West African EVD outbreak. In addition, CDC will use the information gained from the data collection instrument to determine readiness to handle patients with Ebola. The respondent universe for this information collection includes state and 3 municipal health departments and quarantine stations across the U.S.

The planned information collection will administered to state and municipal health departments with the aid of the Council of State and Territorial Epidemiologists. We plan to identify areas of strength in terms of state and municipal health department preparedness. Simultaneously, we will highlight those areas of weakness. This information will be used to inform CDC in the form of an MMWR. The MMWR will present the data in aggregate and no individual state or health departments will be identified. CDC will be able to utilize this information to structure future guidance documents.

Privacy Impact Assessment – No sensitive data are being collected. No individually identifiable information is being collected. The proposed data collection will have little or no impact on respondent privacy. Respondents are participating in their official capacity.

3. Use of Improved Information Technology and Burden Reduction

Data will be collected via a web-based questionnaire (SurveyMonkey) allowing respondents to complete and submit their responses electronically. The data collection instruments will be designed and distributed using Survey Monkey. This method was chosen to reduce the overall burden on respondents. The information collection instrument was designed to collect the minimum information necessary for the purposes of this project.

4. Efforts to Identify Duplication and Use of Similar Information

This assessment represents the first attempt to assess these activities related to state, local, and territorial public health agency readiness activities related to Ebola. There is no information available that can substitute data collection.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this information collection.

6. Consequences of Collecting the Information Less Frequently

This request is for a one time information collection. There are no legal obstacles to reduce the burden. Without this information collection, CDC will be unable to

• Assess state, local, and territorial public health agency readiness to respond to Ebola surrounding the following Ebola-related preparedness capabilities:

• Healthcare System Preparedness

• Emergency Public Information and Warning

• Information Sharing

• Public Health Surveillance and Epidemiology Investigation

• Responder Safety and Health

• Develop technical assistance strategies for assisting with state, local, and territorial readiness activities related to the Ebola response

7. Special Circumstances Relating to the Guidelines of 5CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the regulation 5CFR 1320.5 and will be voluntary.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

This information collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2)-OMB No. 0920-0879. A 60-day Federal Register Notice was published in the Federal Register on October 31, 2013, Vol. 78, No. 211; pp 653 25-26. No comments were received.

CDC partners with professional STLT organization, such as the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH) along with the National Center for Health Statistics (NCHS) to ensure that the collection requests under individuals ICs are not in conflict with collections they have or will have in the filed within the same timeframe.

9. Explanation of Any Payment or Gift to Respondents

CDC will not provide payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondents

The Privacy Act does not apply to this data collection. Employees of state and local public health agencies will be speaking from their official roles and will not be asked, nor will they provide individually identifiable information.

This data collection is not research involving human subjects.

11. Justification for Sensitive Questions

No information will be collected that are of personal or sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on a pilot test of the information collection instrument by five public health professionals. In the pilot test, the average time to complete the data collection instrument including time for reviewing instructions, gathering needed information and completing the instrument, was approximately 10 minutes. Based on these results, the estimated time range for actual respondents to complete the data collection instrument is 8 to 12 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e. 12 minutes) is used. Please note, to the best of our knowledge, there are some states that have not had any PUI inquiries. Estimates for the average hourly wage for respondents are based on the Department of Labor (DOL) National Compensation Survey estimate for management occupations – medical and health services managers in state government (http://www.bls.gov/ncs/ocs/sp/nctb1349.pdf). Based on DOL data, an average hourly wage of $57.11 is estimated for all 53 respondents. Table A-12 shows estimated burden and cost information.

Table A-12: Estimated Annualized Burden Hours and Costs to Respondents

Data Collection Instrument: Form Name	Type of Respondent	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
PUI Ebola Assessment	State, Territorial and Municipal Health Department Epidemiologists	55	1	12/60	11	57.11	628.21
	TOTALS	55	1		11		628.21

13. Estimates of Other Total Annual Cost Burden to Respondents or Record

There will be no direct costs to the respondents other than their time to participate in each information collection.

14. Annualized Cost to the Government

There are no equipment or overhead costs. The only cost to the federal government would be the salary of the CDC staff during data collection and analysis activities. The estimated cost to the federal government is $1493.20. Table A-14 describes how this cost estimate was calculated.

Table A-14: Estimated Annualized Cost to the Federal Government

Staff (FTE)	Average Hours per Collection	Average Hourly Rate	Average Cost
Medical Epidemiologist: Oversight for data collection, data analysis, and reporting	4	50.00	200
Medical Epidemiologist: Oversight for data collection, data analysis, and reporting	4	50.00	200
Epidemic Intelligence Officer	15	36.44	546.60
Epidemic Intelligence Officer	15	36.44	546.60
Estimated Total Cost of Information Collection			1493.20

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

Responses from the survey will be compiled on a spreadsheet. Survey responses will then be used to compose descriptive statistics about these inquiries using either Epi-Info or SAS. Eventually, results of this assessment will be presented in the form of a MMWR. Results may also be presented at the EIS Conference next year. Finally, the data may be used in the future to guide readiness guidelines and protocols.

Project Time Schedule

Design instrument…………………………………………………………………………………………………………..Complete

Pre-test instrument………………………………………………………………………………………………………...Complete

Prepare OMB package……………………………………………………………………………………………………..Complete

Submit OMB package………………………………………………………………………………………………………Complete

OMB approval…………………………………………………………………………………………………………………..Pending

Launch assessment…………………………………………………………………………………………………..Open 1 week

Reminder partial- and non-responders…………………………...Day 3 and Day 6 after Launch assessment

Code, enter, and analyze data…………………………………………………………1 week after assessment close

Prepare final report……………………………………………………………………….2 weeks after assessment close

Delivery final report………………………………………………………………………3 weeks after assessment close

17. Reason(s) Display of OMB Expiration Date is Inappropriate

We are requesting no exemption.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

LIST OF ATTACHMENTS – Section A

Note: Attachments are included as separate files as instructed.

1. Instrument-MS Word

2. Instrument-Web

REFERENCE LIST

1. Centers for Disease Control and Prevention (CDC). “Ebola (Ebola Virus Disease)”. Available at http://www.cdc.gov/vhf/ebola/. Accessed on 9/28/14.

2. Meltzer MI, Atkins CY, Santibanez S, et al. Estimating the Future Number of Cases in the Ebola Epidemic—Liberia and Sierra Leone, 2014-2015. MMWR 2014 September:63(03); 1-14.

3. WHO. Ebola Outbreak 2014: Daily Internal Report, 18^th September; 2014 [cited 19 September 2014]; Available from: http://apps.who.int/iris/bitstream/10665/133833/1/roadmapsitrep4_eng.pdf?ua=1

4. CDC. 2014 Ebola Outbreak Response Situation Report: #29; 2014 [cited 26 September 2014] Available from: http://eoms.cdc.gov/DocumentLibrary.aspx?pg=172&lb=2807&fd=80497 (internal)

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