Emergency Submission to Supplement OMB Control Number 0920-0900 in the context of contact investigations associated with Ebola and travel.
Supporting Statement A
Program Contact
Amy McMillen
Office of Policy and Planning
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS C12
Atlanta, Georgia 30333
Phone: (404) 639-1045
Email: [email protected]
Submission Date: October 15, 2014
Emergency Submission to Supplement OMB Control Number 0920-0900 in the context of contact investigations associated with Ebola and travel.
Supporting Statement
A. Justification
Background
Centers for Disease Control and Prevention (CDC) will perform contact investigations of individuals who may have come into contact with travelers that are confirmed to have Ebola infection. CDC will collaborate with state health departments, conveyance operators, port of entry partners, and international public health authorities. CDC relies on these established public and private sector partnerships to complete contact investigations. CDC’s response requires revising forms recently approved under OMB 0920-0900 and adding an additional form. Above what is already approved in OMB 0920-0900, the total number of respondents and burden requested is 25,233 and 3,967 hours, respectively.
This emergency package covers the following:
In addition to the approved process for conducting contact investigations, CDC is requesting emergency approval for an additional script (Script – Introduction and Confirmation, Attachment A) that CDC staff will use when responding to a traveler that calls CDC in response to a notification that they were on a flight with a confirmed case of Ebola. Notification of travelers may be broad, e.g. public notice via television, or targeted to each individual traveler. This script will enable CDC to confirm who the traveler is, to confirm where the traveler sat in relation to the ill traveler, and will assist CDC in collecting sufficient information to share with the State so that the State can perform the contact investigation of their residents. The scripts will also provide CDC with an opportunity to notify travelers that CDC will be sharing their information with the appropriate health department. CDC will prepopulate information such as flight details and health department details so that each script is specific to the contact investigation (fields are highlighted).
Change the temperature at which CDC should be notified immediately from 101.5F (38.6C) to 100.4F (38C) on the currently approved Ebola Airline Exposure Assessment Passenger Form (Attachment B), Ebola Airline Exposure Assessment Flight Crew Form (Attachment C), Ebola Airline Exposure Assessment Cleaning Crew Form (Attachment D), and Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff (Attachment E). There is no additional burden as a result of this request to change 0920-0900. CDC staff may prepopulate the flight information and last date for which an individual should monitor their health (fields are highlighted).
An increase in burden to account a larger estimate of the number of contact investigations due to ill travelers confirmed to have Ebola. This increase in burden applies to the currently approved in OMB No. 0920-0900: Ebola Airline Exposure Assessment Passenger Form (Attachment B), Ebola Airline Exposure Assessment Flight Crew Form (Attachment C), Ebola Airline Exposure Assessment Cleaning Crew Form (Attachment D), and Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff (Attachment E).
This is a request for additional information collection tools to supplement CDC’s Ebola-related contact investigation activities so that CDC can better assess the risk to individuals who may have been exposed to a confirmed case of Ebola while traveling to or within the United States.
The scripts that CDC is requesting will be used in the following manner.
If a traveler calls CDC, CDC staff will use Script – Introduction and Confirmation. This script will ask the respondent to provide name and contact information, flight information, a phone number where they can be reached in case the call is disconnected, and seat number. Travelers will also be informed that their state or local health departments will be following up with them.
2.1 Privacy Impact Assessment
Highly sensitive information is being collected that would affect a respondent’s privacy if there were a breach of security. However, stringent safeguards are in place to ensure a respondent’s privacy including authorized users, physical safeguards, and procedural safeguards. Authorized users: A database security package is implemented on CDC’s computer systems to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of CDC or its contractors as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected. Physical safeguards: Access to the CDC facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric code) system. Access to the data entry area is also controlled by a cardkey system. Guard service in buildings provides personnel screening of visitors. The computer room is protected by an automatic sprinkler system, numerous automatic sensors are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. Computer files are backed up on a routine basis. Hard copy records are stored in locked cabinets at CDC headquarters and CDC Quarantine Stations which are located in a secure area of the airport. Procedural safeguards: Protections for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily back-up procedures, and secure off-site storage is available. To avoid inadvertent data disclosure, measures are taken to ensure that all data are removed from electronic medical containing Privacy Act information. Finally, CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts and the CDC Project Director, contract officers and project officers oversee compliance with these requirements.
The majority of responses are submitted using secure e-mail or fax. Should CDC need to contact an individual directly, either telephone or email will be used depending on availability and reliability of contact information. If a traveler calls CDC using the phone line, the telephone will be used.
CDC retains the regulatory authority for performing quarantine-related activities at U.S. ports of entry (42 Part 71) and for travel between states (42 CFR 70). One such activity is providing pertinent passenger information to state and local health departments and maritime operators for the notification of those who may have been exposed to communicable disease during travel. CDC is the only agency that provides this information, and the health department of jurisdiction or airline staff or maritime operator is the only entity that conducts the contact investigations. In addition, CDC works in collaboration with its international, federal, state, and local partners to ensure all contact investigations due to a communicable disease exposure during travel are done in a coordinated manner. There is no duplication of data.
None
If CDC does not collect this information, there is an increased risk of ill passengers coming in contact with the general public.
None
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A. OMB has waived the 60 day public comment period.
B. CDC has worked with health departments and private sector partners on numerous occasions to conduct contact investigations of ill travelers. CDC will continue do so using these new and revised tools.
No monetary incentives or gifts are provided to respondents.
This information collection request has been reviewed by the CDC Information Collection Review Office (ICRO). The ICRO has determined that the Privacy Act does apply to some aspects of this information collection request. The applicable System of Records Notice is 09-20-0171, Quarantine and Traveler Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71 .
Information submitted will be entered into a computer system for analysis and later retrieved if necessary. Data containing personal identifiers and source documents will be retained until the event prompting the collection of data has concluded in accordance with DGMQ’s records retention schedule. Data not containing personal identifiers will be retained indefinitely for statistical and historical documentation purposes. Electronic media will be protected by adequate physical, administrative, and procedural safeguards to ensure the security of the data. Access will be restricted to agency employees with a bona fide “need to know” in order to carry out the duties of their positions or to accomplish the purposes for which the data were collected. When information is deleted, a special “certified” process will be used to completely overwrite tapes on the mainframe or overwriting (not merely deleting) microcomputer files. Source documents, printouts and thumb drives will be safeguarded by storing them in locked cabinets in locked offices when not in use.
10.1 Privacy Impact Assessment Information
Privacy Impact Assessment Information
1. Respondents to this data collection will be informed whether or not providing the data described in this supporting statement is mandatory or voluntary.
2. Respondents indicate their consent by verbally agreeing to participate in the screening program.
3. Highly sensitive information is being collected and would affect a respondent’s privacy if there were a breach of security. This information is collected under the Privacy Act system of records notice 09-20-0171, “Quarantine and Traveler Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71”, published in the Federal Register, Vol. 72, No. 238, December 13, 2007, pp. 70867-70872. However, stringent safeguards are in place to ensure a respondent’s privacy including restriction of access to authorized users, physical safeguards, and procedural safeguards. Authorized users: A database security package is implemented on CDC’s computer systems to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of CDC or its contractors as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected. Physical safeguards: Access to the CDC facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric code) system. Access to the data entry area is also controlled by a cardkey system. Guard service in buildings provides personnel screening of visitors. The computer room is protected by an automatic sprinkler system, numerous automatic sensors are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. Computer files are backed up on a routine basis. Hard copy records are stored in locked cabinets at CDC headquarters and CDC Quarantine Stations. Procedural safeguards: Protections for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily back-up procedures, and secure off-site storage is available. To avoid inadvertent data disclosure, measures are taken to ensure that all data are removed from electronic media containing Privacy Act information. Finally, CDC and contractor employees who maintain and use records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts, the CDC Project Director, contract officers and project officers oversee compliance with these requirements, and CDC employees and contractors are required to be trained on the Privacy Act and receive information security awareness training at least annually.
4. This data collection are subject to the Privacy Act. The existing applicable Systems of Records Notice is 09-20-0171.
This information collection requests certain personally identifying information of both imports and travelers. Some personally identifying information will be collected during the proposed risk assessments in order to identify ill travelers. Some travelers might find these questions sensitive in nature, but this information is necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States.
Below are the estimates of the Burden Hours for Six Months that are not already included in the OMB No. 0920-0900. Above what is already approved in OMB 0920-0900, the total number of respondents and burden requested is 25,233 and 3,967 hours, respectively. This estimate represents an upper-bound and was not arrived at through epidemiological modeling or other scientific techniques. The estimate is a contingency to ensure that CDC has requested adequate public burden in the even that more contact investigations are needed.
This estimate is based on the following assumptions and estimates:
It is common for index case to connect from an international flight to a domestic flight, since international flights rarely land at the airport closest to index’s home. This will result in double the amount of potential contacts. This estimate also includes flights that originate and terminate within the United States.
In the past CDC has requested the ability to contact at least 17 passengers on a flight who may have had close contact with an ill traveler. The generally covers 14-15 travelers who are sitting in the close contact zone as well as other individuals who may have had close contact. CDC requests the ability to use the already approved contact investigation forms, with the change of temperature notice, for 50 contact investigations instead of 10.
CDC anticipates that every individual on a flight with a confirmed case will call CDC and will respond to questions in Script – Introduction and Confirmation. This is approximately 250 individuals per flight, multiplied by two flights per index case, multiplied by 50 contact investigations. This comes to a total of 25,000 total respondents.
Of those 25000 respondents CDC, anticipates that 1700 travelers who are in a close contact zone or otherwise had contact with the ill traveler may need to be contacted using the Ebola Airline Exposure Assessment Passenger Form.
CDC anticipates that 1200 flight crew may need to be contacted using the Ebola Airline Exposure Assessment Flight Crew Form. This is approximately 12 per flight for each of the 50 contact investigations.
CDC anticipates that 600 cleaning crew may need to be contacted using the Ebola Airline Exposure Assessment Form. This is six crew members per flight for each of the 50 contact investigations.
CDC anticipates that 500 port of entry staff may need to be contacted using the Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff Form. This is five staff per flight, for 50 contact investigations.
12 A. Estimates of Annualized Burden Hours
Type of Respondent |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden Hours |
Passenger
|
Ebola Airline Exposure Assessment Passenger |
1700 |
2 |
20/60 |
1133 |
Flight Crew
|
Ebola Airline Exposure Assessment Flight Crew |
1200 |
2 |
20/60 |
800
|
Cleaning Crew
|
Ebola Airline Exposure Assessment Cleaning Crew |
600 |
2 |
20/60 |
400 |
Airport or Other Port of Entry Staff
|
Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff |
500 |
2 |
20/60 |
333 |
Traveler |
Script – Introduction and Confirmation |
25000 |
1 |
5/60 |
2083 |
Total |
|
29000 |
|
|
4749 |
The total estimates for respondents and burden for the contact investigation and Ebola exposure assessment are below. All wages are from the Bureau of Labor Statistics Occupational Employment and Wages, May 2013. CDC estimates an additional $88,071 of respondent cost as a result of this emergency request.
Wages for Passengers were gathered from 00-0000 All Occupations (http://www.bls.gov/oes/current/oes_nat.htm#00-0000)
Wages for Flight Crew were gathered from 53-2011 Airline Pilots, Copilots, and Flight Engineers (http://www.bls.gov/oes/current/oes532011.htm) and 53-2031 Flight Attendants (http://www.bls.gov/oes/current/oes532031.htm). A weighted average wage taking into account a full crew per flight of three pilots and nine flight attendants is used for the hourly wage column.
Wages for Airline Cleaning Crew were gathered from 53-7061 Cleaners of Vehicles and Equipment (http://www.bls.gov/oes/current/oes537061.htm)
Given the variety of professional staff who may interact with a potential case at a port of entry, the estimated hourly wage used is 00-0000 All Occupations (http://www.bls.gov/oes/current/oes_nat.htm#00-0000)
12 B. Estimates of Annualized Cost
Type of Respondent |
Form |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
Passenger
|
Ebola Airline Exposure Assessment Passenger |
1133 |
$22.33
|
$25,300 |
Flight Crew
|
Ebola Airline Exposure Assessment Flight Crew |
800
|
$31.29
|
$25,032 |
Cleaning Crew
|
Ebola Airline Exposure Assessment Cleaning Crew |
400 |
$11.05
|
$4,420 |
Airport or Other Port of Entry Staff
|
Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff |
333 |
$22.33
|
$7436 |
Traveler |
Script – Introduction and Confirmation |
2083 |
$22.33
|
$46,513 |
Total |
|
4749 |
|
$108,701 |
There is no additional cost burden.
There are no exceptions to the certification.
CDC and CPB may report aggregate totals of number of people screened and number of positives publicly, as appropriate.
Display of the expiration date is appropriate. No exemption is requested.
There are no exceptions to the certification.
Attachment A – Script – Introduction and Confirmation
Attachment B - Ebola Airline Exposure Assessment Passenger Form
Attachment C - Ebola Airline Exposure Assessment Flight Crew
Attachment D - Ebola Airline Exposure Assessment Cleaning Crew
Attachment E - Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff
| File Type | application/msword |
| File Title | Foreign Quarantine Regulations (42 CFR 71) |
| Author | aeo1 |
| Last Modified By | CDC User |
| File Modified | 2014-10-16 |
| File Created | 2014-10-15 |