0920-0900 Supporting Statement A -10082014

The Centers for Disease Control and Prevention (CDC), Division of Global Migration and Quarantine (DGMQ) requests a revision of the currently approved Information Collection Request: “Contact Investigation Outcome Reporting Forms,” expiring September 30, 2014. CDC has conducted a thorough review of the data collection tools approved in this information collection request. To streamline the data collected, ease the completion of each data collection tool, and to target information collected to be more specific to the individual illness of public health concern, several changes to the data collection tools have been proposed. The result is a 179% increase in burden, or an increase of 502 total burden hours. A summary of changes is as follows:

Data pertaining to contact investigations for measles, mumps and rubella will no longer be collected using one form for either the air or maritime environments.
- Data collection for measles contact investigations will be collected either by using the Measles Contact Investigation Reporting Form – Air (Attachment J), or the Measles Contact Investigation Reporting Form – Maritime (Attachments K and L).
- CDC will no longer collect information pertaining to cases of mumps occurring during air travel. Contact investigations for cases of mumps occurring onboard maritime conveyances will still be evaluated, using the General Contact Investigation Outcome Form - Maritime (Attachments D and E).
- Data collection for rubella contact investigations will be collected either by using the Rubella Contact Investigation Reporting Form – Air (Attachment M), or the Rubella Contact Investigation Reporting Form – Maritime (Attachments N and O). Data collection fields pertaining to pregnant women have been added to assist in recommending the appropriate prophylaxis of those exposed.

Data pertaining to contact investigations occurring in the air and land-border crossing environments will no longer be collected using the same form. Factors affecting the disease transmission in these environments is very different, thus, CDC has created separate data collection tools and fields. Data collection for contact investigations of illnesses of public health concern occurring in a land-border crossing environment will be collected by using the General Contact Investigation Reporting Form – Land (Attachment F). Data collection for illnesses of public health concern occurring in an air environment will be collected using tools specific to each disease (Attachments C, G, J and M).

In response to a request from maritime operators (cruise ship physicians/cargo ship managers), CDC has added the option for contact investigation outcome reporting to be completed in either a MS Word or MS Excel format. The excel format allows reporting for multiple patients simultaneously without completing separate documents for each ill traveler. The information collected on each of the data collection tools is the same. Data collection for contact investigations for diseases of public health concern occurring in a maritime environment will be collected using tools specific to each disease (Attachments D, E, H, I, K, L, N and O).

In response to the outbreak of Ebola in West Africa, in collaboration with state health departments, conveyance operators, port of entry partners, and international public health authorities, the 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 relies on these established public and private sector partnerships to complete contact investigations. As such, CDC requests the addition of four forms:
- Ebola Airline Exposure Assessment Passenger (Attachment P)
- Ebola Airline Exposure Assessment Flight Crew (Attachment Q)
- Ebola Exposure Assessment Cleaning Staff (Attachment R)
- Ebola Exposure Assessment Airport or Other Port of Entry Staff (Attachment S)

This data collection supports the need for CDC staff to evaluate cases of communicable diseases of public health concern during travel and conduct investigative contact tracing for those that may have been exposed. The proposed data collection tools (Attachments C-O) facilitate the collection of data pertaining to these investigations.

Section 361 of the Public Health Service (PHS) Act (42 USC 264) (Attachment A.1) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the United States. Under its delegated authority, CDC works to fulfill this responsibility through a variety of activities, including the operation of Quarantine Stations at ports of entry and administration of foreign and interstate quarantine regulations; 42 CFR Parts 70 and 71 (Attachment A.2 and A.3), respectively. These regulations require conveyances to immediately report an ill person or any death to the Quarantine Station of jurisdiction prior to arrival in the United States.

When an illness or death suggestive of a communicable disease is reported during travel (reported under 0920-0134 Foreign Quarantine Regulations), Quarantine Officers respond to carry out an onsite public health assessment and collect pertinent information using “Illness Response and Investigation Forms”, OMB 0920-0821 (expiring 8/31/2015). The public health response may differ depending upon the assessment of an ill/deceased person. One such response is determining that passengers need to be notified if exposed to the communicable disease during travel. This notification of passengers is critical to preventing the spread of communicable disease because it allows for timely implementation of public health measures needed to mitigate or stop further spread of disease.

The responsibility for contacting exposed passengers typically falls with state or local health departments or with maritime operators, if travel occurred on a ship. The extent of the contact investigation that determines which passengers are believed to have been exposed to a communicable disease is based on CDC investigative protocols. CDC is also responsible for providing state and local public health authorities with adequate contact information, such as phone numbers and address, to facilitate successful notification of the exposed passengers. The success of preventing the spread of a communicable disease is due in large part to the effectiveness of the CDC’s investigative protocols and the provision of contact information. CDC’s ability to control the spread of communicable disease through implementing effective investigative protocols is impaired without comprehensive feedback indicating the outcome of the notification and contact investigation from state and local health departments or from maritime conveyance operators.

Privacy Impact Assessment

Overview of the Data Collection System

CDC’s Division of Global Migration and Quarantine has developed contact investigation outcome reporting forms for the different types of contact investigations. These forms are used to collect information on the outcome of contact investigations so that CDC can determine if adequate information was provided to those responsible for contacting passengers believed to have been exposed to a communicable disease during travel. These forms include:

General Contact Investigation Outcome Reporting Form – Air (Attachment C)
General Contact Investigation Outcome Reporting Form – Maritime (Word version) (Attachment D)
General Contact Investigation Outcome Reporting Form –(Excel version) (Attachment E)
General Contact Investigation Outcome Reporting Form – Land (Attachment F)
TB Contact Investigation Outcome Reporting Form – Air (Attachment G)
TB Contact Investigation Outcome Reporting Form – Maritime (Word version) (Attachment H)
TB Contact Investigation Outcome Reporting Form –(Excel version) (Attachment I)
Measles Contact Investigation Outcome Reporting Form – Air (Attachment J)
Measles Contact Investigation Outcome Reporting Form – Maritime (Word version) (Attachment K)
Measles Contact Investigation Outcome Reporting Form –(Excel version) (Attachment L)
Rubella Contact Investigation Outcome Reporting Form – Air (Attachment M)
Rubella Contact Investigation Outcome Reporting Form – Maritime (Word version) (Attachment N)
Rubella Contact Investigation Outcome Reporting Form –(Excel version) (Attachment O)
Ebola Airline Exposure Assessment Passenger (Attachment P)
Ebola Airline Exposure Assessment Flight Crew (Attachment Q)
Ebola Exposure Assessment Cleaning Staff (Attachment R)
Ebola Exposure Assessment Airport or Other Port of Entry Staff (Attachment S)

Each of these data collection tools reflect specific questions unique to the communicable disease of public health concern specified. These forms provide the means for state and local public health officials, as well as cruise ship physicians and cargo ship managers to communicate information to CDC information regarding contact investigations. The method of collecting information is determined by those conducting the contact investigation.

Data collected from state and local health departments or maritime operators will be maintained by CDC in accordance with the CDC records retention schedule: Communicable Disease Case Study Files (NC1-90-83-2, Item 1).

With respect to the cases associated with Ebola prevention efforts, the 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.

In general, state health departments will collect information on passengers using the Ebola Airline Exposure Assessment Passenger form developed by CDC. An email with instructions will be used to send the forms to states with instructions for conducting the interviews, which will be completed by phone. Hard copies of the interview form should be printed, completed, and returned to CDC as instructed. Instructions will include request to those performing the interviews that the initial interview and final disposition be sent back to CDC via secure fax. Information will be entered into a secure CDC database.

For airline and port of entry staff, once CDC is made aware of any potential exposure to the confirmed case, appropriate points of contact for flight crew, cleaning crew, and port of entry staff will be identified. The Ebola Airline Exposure Assessment Flight Crew, Ebola Exposure Assessment Cleaning Crew and Ebola Exposure Assessment Airport or Other Port of Entry Staff interview forms will be sent via email to the airline and port of entry authority for use in conducting their interviews. Airline and port of entry occupational health will collect information on flight crew, cleaning crew, and port of entry staff using the tools developed by CDC. Health departments may assist airports, airlines, and other ports of entry as needed and may be involved in follow-up with any individuals depending on risk or as needed.

In some cases, CDC staff may need to conduct interviews directly, e.g. in the case of a US citizen overseas or if the state was unable to conduct interviews for their residents. In the vast majority of cases, state and local health authorities are able to conduct the interviews.

Information will be collected twice: an initial interview and then a final disposition interview after the 21 day incubation period from day of flight has expired. The same form will be used for the initial interview and final disposition interview. Interviews may be conducted by telephone or in person. CDC requests that hard copies of the tools be printed by our partners, completed, and returned to CDC via secure fax. Information will be entered into a secure CDC database.

Items of Information to be Collected

These forms include the following information in identifiable form: medical information, date of birth, gender, country of birth, and country of residence. These data are compiled from existing sources. The forms provide a uniform approach for relaying information pertinent to communicating the outcome of each investigation.

2. Purpose and Use of Information Collection

The information collected on the forms enables CDC to more fully understand the extent of disease spread and transmission during travel. This information assists in the development and/or refinement of investigative protocols, aimed at reducing the spread of communicable disease.

The purpose of the proposed contact investigation outcome reporting forms is to uniformly collect information from state and local health department officials as well as maritime operators conducting contact investigations on behalf of CDC. This information enables CDC to assess, detect, and respond efficiently and accurately to communicable disease threats of potential public health concern at ports of entry. The information collected is also necessary for public health surveillance (tracking) and follow-up purposes. The forms collect the following categories of information: demographics, pertinent clinical and medical history, and epidemiologic and travel history.

This information enables CDC staff to assist conveyances and border agents in the public health management of ill persons at U.S. ports and plan the appropriate response. This data is then entered into the Quarantine Activities Reporting System (QARS), a secure web-based, data-management system used by all Quarantine Stations to record information about the daily activities of Quarantine Station staff.

QARS is a secure intranet system implemented in June 2005 to track the number of illnesses and deaths reported to Quarantine Stations that occurred on conveyances and land border crossings entering the United States. In addition, QARS is used to store information on Quarantine Station activities such as: emergency preparedness and partnership activities, interaction with public health and other port partners, medical paperwork processing for aliens and immigrants, the importation of nonhuman primates and other animals, and drug releases (botulism and diphtheria anti-toxins and malaria treatment).

2.1 Privacy Impact Assessment

The purpose of the contact investigation is to stop the spread of disease. The purpose of the forms is to inform CDC if existing protocols need to be refined.

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.

3. Use of Improved Information Technology and Burden Reduction

The majority of responses are submitted using secure e-mail or fax. CDC has introduced an excel version of the maritime outcome reporting forms to reduce burden and ease the submission of data for multiple individuals using one format.

4. Efforts to Identify Duplication and Use of Similar Information

CDC retains the regulatory authority for performing quarantine-related activities at U.S. ports of entry (42 Part 71). 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 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.

5. Impact on Small Businesses or Other Small Entities

The proposed information collection request does not impact small businesses or other small entities. Respondents are primarily state and local health department officials, and cruise ship physicians or cargo ship managers.

6. Consequences of Collecting the Information Less Frequently

Frequency of the proposed data collection is determined by the incidence of travelers who develop an illness or die from a communicable disease of public health concern. Information will only be collected if these incidences occur during travel by air or maritime conveyance and reported to a quarantine station at a port of entry. Control of communicable diseases of public health concern is dependent on rapid identification and immediate response when identified. Information will only be collected when it is essential to protect the public’s health. Further reduction of required reporting would prevent CDC from meeting its legislative mandate, thereby endangering the public’s health.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. A notice detailing the proposed data collection activities was published in the Federal Register on, Wednesday, May 14, 2014, Vol. 79, PP 27618- 27619. (Attachment B). No comments were received.

B. CDC did not consult with outside persons on the development of these forms. The forms represent data that is already captured by state and local health departments and maritime operators. CDC collects these data on a voluntary basis. The forms are tools to facilitate transfer of this information to CDC.

9. Explanation of Any Payment or Gift to Respondents

No monetary incentives or gifts are provided to respondent

10. Assurance of Confidentiality Provided to Respondents

CDC will assure the security of respondents based on procedures implemented in accordance with the Privacy Act. These forms are maintained as a system of records under the Privacy Act system notice 0920-0171, “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. Stringent safeguards are in place to ensure a respondent’s privacy including authorized users, physical safeguards, and procedural safeguards.

IRB Approval

IRB approval is not needed for this information collection request.

Privacy Impact Assessment Information

This submission has been reviewed by NCEZID who has determined that the Privacy Act does apply. The applicable System of Records Notice is “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. The voluntary information collected from travelers will be kept secure and will not be disclosed to anyone unless necessary to carry out their regulatory responsibilities or as otherwise required by law. No changes to the storage or security of Personally Identifiable Information outlined in the currently approved information collection are proposed for this revision request.

Respondents to this data collection are state and local health departments and maritime conveyance operators and response to these forms is voluntary. CDC is not collecting data directly from the ill traveler or contact; therefore, no consent or script to conduct such an interview is needed.

The information being collected is highly sensitive and 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.

Parts of this data collection are subject to the Privacy Act. The existing applicable Systems of Records Notice for this revision is 09-20-0171.

11. Justification for Sensitive Questions

These forms collect three types of data: 1) Epidemiologic data such as travel itinerary, clinical signs and symptoms, exposure to ill people or animals, history of illness are essential to accurately determining the public health risk; 2) Demographic data such as age, race, sex, and geographic location are routinely collected as part of standard public health surveillance; and 3) Clinical information (symptom development, medical evaluation, lab testing, etc.) All of these data elements are essential to efficiently detect a public health threat and rapidly implement appropriate public health control measures to prevent the introduction and spread of communicable disease in the U.S.

12. Estimates of Annualized Burden Hours and Costs

Estimate of Annualized Burden Hours

The number of times these data are collected remains dependent upon the number of outbreaks of public health concern that occur within each data collection period. Estimated burden in many of the forms detailed below has changed significantly (both higher and lower) since the last approved data collection period.

Based on the average of the actual contact investigations conducted between 2011-2014, CDC estimates that the number of contacts will be approximately 3,777 annually. However, the actual number of contacts remains dependent upon the types and scale of outbreaks that occur each year.

The estimated time to complete the forms remains approximately five minutes for all forms except the Ebola-related forms, which will take approximately 20 minutes to complete. Completion of each form is dependent upon the ability to contact the individual believed to have been exposed to a communicable disease. If contact was made, the burden estimates below are based upon the time it would take to relay the pertinent information they have collected to the CDC standardized forms.

CDC is requesting an additional 534 hours of respondent burden each year to accommodate the four Ebola specific tools in this information collection request, for a revised annual total of 782 hours.

The following is an estimate of the number of respondents and burden that may result in the course of CDC’s contact investigation for potentially exposed travelers. These estimates are constructed using the following considerations:

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.
Per established Ebola contact investigation protocol, the number of passengers that need to be contacted per flight is < 14, based on a designated zone of seats around the infected traveler. In this response, CDC is requesting an additional three per flight to account for babes in arms, passenger movement before or during flight, and passengers who may have provided assistance to the ill traveler.
In addition, CDC estimates that airline and port of entry staff may need to be contacted. CDC estimates three pilots and nine cabin crew for each flight, six cleaning staff per flight, and five potential contacts at the port of entry. These numbers are also doubled based on the possible two flight/two airport scenario.

12A. Estimate 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
State/local health department staff	General Contact Investigation Outcome Reporting Form (Air)	12	1	5/60	1
Cruise Ship Physicians/ Cargo Ship Managers	General Contact Investigation Outcome Reporting Form (Maritime – word version)	100	1	5/60	8
Cruise Ship Physicians/ Cargo Ship Managers	General Contact Investigation Outcome Reporting Form (Maritime – Excel version)	100	1	5/60	8
State/local health department staff	General Contact Investigation Outcome Reporting Form (Land)	12	1	5/60	1
State/local health department staff	TB Contact Investigation Outcome Reporting Form (Air)	1,244	1	5/60	104
Cruise Ship Physicians/ Cargo Ship Managers	TB Contact Investigation Outcome Reporting Form (Maritime - word version)	150	1	5/60	13
Cruise Ship Physicians/ Cargo Ship Managers	TB Contact Investigation Outcome Reporting Form (Maritime - Excel version)	150	1	5/60	13
State/local health department staff	Measles Contact Investigation Outcome Reporting Form (Air)	964	1	5/60	80
Cruise Ship Physicians/ Cargo Ship Managers	Measles Contact Investigation Outcome Reporting Form (Maritime – word version)	63	1	5/60	5
Cruise Ship Physicians/ Cargo Ship Managers	Measles Contact Investigation Outcome Reporting Form (Maritime – excel version)	63	1	5/60	5
State/local health department staff	Rubella Contact Investigation Outcome Reporting Form (Air)	95	1	5/60	8
Cruise Ship Physicians/ Cargo Ship Managers	Rubella Contact Investigation Outcome Reporting Form (Maritime –word version)	12	1	5/60	1
Cruise Ship Physicians/ Cargo Ship Managers	Rubella Contact Investigation Outcome Reporting Form (Maritime – excel version)	12	1	5/60	1
Passenger	Ebola Airline Exposure Assessment Passenger	340	2	20/60	227
Flight Crew	Ebola Airline Exposure Assessment Flight Crew	240	2	20/60	160
Cleaning Crew	Ebola Exposure Assessment Cleaning Staff	120	2	20/60	80
Airport or Other Port of Entry Staff	Ebola Exposure Assessment Airport or Other Port of Entry Staff	100	2	20/60	67
Total					782

Estimate of Annualized Burden Cost

To estimate annualized burden cost, we have taken the average wage or median income of Epidemiologists, which is $35.11 per hour (according to the U.S. Department of Labor Statistics, http://www.bls.gov/oes/current/oes191041.htm). We assume salaries would be more or less equivalent for Epidemiologists, Cruise Ship Physicians/Cargo Ship Managers.
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)

12B. Estimate of Annualized Burden Cost

Type of Respondent	Form Name	Total Burden Hours	Wage Rate	Costs
State/local health department staff	General Contact Investigation Outcome Reporting Form (Air)	1	$35.11	$35
Cruise Ship Physicians/ Cargo Ship Managers	General Contact Investigation Outcome Reporting Form (Maritime – word version)	8	$35.11	$281
Cruise Ship Physicians/ Cargo Ship Managers	General Contact Investigation Outcome Reporting Form (Maritime – Excel version)	8	$35.11	$281
State/local health department staff	General Contact Investigation Outcome Reporting Form (Land)	1	$35.11	$35
State/local health department staff	TB Contact Investigation Outcome Reporting Form (Air)	104	$35.11	$3,652
Cruise Ship Physicians/ Cargo Ship Managers	TB Contact Investigation Outcome Reporting Form (Maritime - word version)	13	$35.11	$456
Cruise Ship Physicians/ Cargo Ship Managers	TB Contact Investigation Outcome Reporting Form (Maritime - Excel version)	13	$35.11	$456
State/local health department staff	Measles Contact Investigation Outcome Reporting Form (Air)	80	$35.11	$2,809
Cruise Ship Physicians/ Cargo Ship Managers	Measles Contact Investigation Outcome Reporting Form (Maritime – word version)	5	$35.11	$176
Cruise Ship Physicians/ Cargo Ship Managers	Measles Contact Investigation Outcome Reporting Form (Maritime – excel version)	5	$35.11	$176
State/local health department staff	Rubella Contact Investigation Outcome Reporting Form (Air)	8	$35.11	$281
Cruise Ship Physicians/ Cargo Ship Managers	Rubella Contact Investigation Outcome Reporting Form (Maritime –word version)	1	$35.11	$35
Cruise Ship Physicians/ Cargo Ship Managers	Rubella Contact Investigation Outcome Reporting Form (Maritime – excel version)	1	$35.11	$35
Passenger	Ebola Airline Exposure Assessment Passenger	227	$22.33	$5,067
Flight Crew	Ebola Airline Exposure Assessment Flight Crew	160	$22.33	$3,573
Cleaning Crew	Ebola Airline Exposure Assessment Cleaning Crew	80	$22.33	$1,786
Airport or Other Port of Entry Staff	Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff	67	$22.33	$1,496
	Total	782		$20,630

13. Estimates of Other Total Annual cost burden to Respondents or Record Keepers

There is no other total annual cost burden to respondents or record keepers.

14. Annualized Cost to the Government

As defined by CDC’s regulatory authority and responsibility, the collection of these data is ongoing. The estimated average yearly cost to the Federal government is $29,417. This estimate includes time for CDC staff to analyze these data, as well as enter and maintain the data within the Quarantine Activities Reporting System, which securely houses the information once collected.

Data Analysis Costs:

Staff GS Level	Average annual salary of staff reviewing data	Percentage of time reviewing contact investigation data	Total Cost
GS-12	$72,620	10%	$7,262
GS-12	$72,620	10%	$7,262
GS-12	$72,620	10%	$7,262
Total:			$21,786

Data Entry and Maintenance Costs:

Staff GS Level	Average annual salary of staff entering and maintaining data	Percentage of time entering and maintaining the investigation data	Total Cost
GS-12	$72,620	5%	$3,631
GS-9	$50,007	8%	$4,000
Total:			$7,631

15. Explanation for Program Changes or Adjustments

CDC has conducted an extensive review of the data to be collected. All forms have been streamlined and revised to increase the ease of data collection and to reduce burden on the public. Based on the annual average of the contact investigations conducted between 2011 and 2014, CDC estimates that the number of contacts will be approximately 3,777 annually.

The changes in burden, as well rationales for those changes are summarized below:

General Contact Investigation Outcome Reporting Form (Air) (Attachment C) – the previous data collection period included contact investigations related to the H1N1 pandemic in 2010. Without this type of targeted outbreak event, general air contact investigations have decreased 97%, resulting in a reduction of 37 total burden hours annual. A data specific to land-border crossing contact investigations will be captured in a separate form.

General Contact Investigation Outcome Reporting Form (Maritime – word version) (Attachment D) - This form includes data collection for contact investigations pertaining to a variety of diseases of public health concern, including mumps, which was previously collected on a form for measles, mumps and rubella.

General Contact Investigation Outcome Reporting Form (Maritime – Excel version) (Attachment E) – this is a new data collection method. Ships will have the option to use either the word version or excel version of the form. The project number of responses has been divided evenly amongst the two collection methods.

General Contact Investigation Outcome Reporting Form (Land) (Attachment F) – this is a new data collection tool with data fields more specific to contact investigations occurring in a land-border crossing environment.

TB Contact Investigation Outcome Reporting Form (Air) (Attachment G) – the average number of responses since the last data collection period has decreased by 42%, resulting in the reduction of 76 total burden hours on an annual basis.

TB Contact Investigation Outcome Reporting Form (Maritime - word version) (Attachment H) – Reports of TB occurring on maritime conveyances rose 58% since the last approved data collection, resulting in the increase of 9 total burden hours on an annual basis.

TB Contact Investigation Outcome Reporting Form (Maritime - Excel version) (Attachment I) - This is a new data collection method. Ships will have the option to use either the word version or excel version of the form. The project number of responses has been divided evenly amongst the two collection methods.

Measles Contact Investigation Outcome Reporting Form (Air) (Attachment J) – In order to capture information targeted to specific illnesses, CDC has created separate data collection tools for measles and rubella. Contact investigations for cases of mumps occurring on air conveyances are no longer conducted. The estimated burden for this data collection is a total of 80 hours annually.

Measles Contact Investigation Outcome Reporting Form (Maritime – word version) (Attachment K) - The estimated number of cases of measles occurring in a maritime environment has decreased slightly since the last approved data collection, resulting in an decrease of 2 burden hours, or 10 total hours annually.

Measles Contact Investigation Outcome Reporting Form (Maritime – excel version) (Attachment L) - This is a new data collection method. Ships will have the option to use either the word version or excel version of the form. The project number of responses has been divided evenly amongst the two collection methods.

Rubella Contact Investigation Outcome Reporting Form (Air) (Attachment M) - In order to capture information targeted to specific illnesses, CDC has created separate data collection tools for measles and rubella. Contact investigations for cases of mumps occurring on air conveyances are no longer conducted. The estimated burden for this data collection is a total of 8 hours annually.

Rubella Contact Investigation Outcome Reporting Form (Maritime –word version) (Attachment N) - The estimated number of cases of rubella occurring in a maritime environment has remained the same since the last approved data collection, resulting in an estimation of 1 burden hour annually.

Rubella Contact Investigation Outcome Reporting Form (Maritime – excel version) (Attachment O) - this is a new data collection method. Ships will have the option to use either the word version or excel version of the form. The project number of responses has been divided evenly amongst the two collection methods.

Ebola Airline Exposure Assessment Passenger Form (Attachment P) - this is a new data collection method. 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. Per established Ebola contact investigation protocol, the number of passengers that need to be contacted per flight is < 14, based on a designated zone of seats around the infected traveler. In this response, CDC is requesting an additional three per flight to account for babes in arms, passenger movement before or during flight, and passengers who may have provided assistance to the ill traveler.

Ebola Airline Exposure Assessment Flight Crew (Attachment Q) - this is a new data collection method. CDC estimates that airline staff may need to be contacted. CDC estimates three pilots and nine cabin crew for each flight. These numbers are also doubled based on the possible two flight/two airport scenario.

Ebola Airline Exposure Assessment Cleaning Crew (Attachment R) - this is a new data collection method. CDC estimates that airline and port of entry staff may need to be contacted. CDC estimates six cleaning staff per flight. These numbers are also doubled based on the possible two flight/two airport scenario.

Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff (Attachment S) - this is a new data collection method. CDC estimates that port of entry staff may need to be contacted. CDC estimates five potential contacts at the port of entry. These numbers are also doubled based on the possible two flight/two airport scenario.

16. Plans for Tabulation and Publication and Project Time Schedule

The proposed activities are routine and reoccurring data collections, the time schedules for which are determined by the frequency of exposure to a communicable disease resulting in a contact investigation. Both daily and incident specific reports are generated for CDC staff using QARS data. Quarantine staff plan to use the data, aggregated to protect the privacy of any individually identifiable information, to provide the public, partners, and other stakeholders information about contact investigation and to evaluate and improve CDC’s investigative protocols. Data are not collected for statistical use. There are no current plans to publish any information collected in this request.

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

The display of the OMB expiration date is appropriate. No exemption requested.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

List of Attachments:

Attachment A.1: Section 361 of the Public Health Service (PHS) Act (42 USC 264)

Attachment A.2: 42 CFR part 70

Attachment A.3: 42 CFR part 71

Attachment B: 60 Day Federal Register Notice

Attachment C: General Contact Investigation Outcome Reporting Form (Air)

Attachment D: General Contact Investigation Outcome Reporting Form

(Maritime – word version)

Attachment E: General Contact Investigation Outcome Reporting Form

(Maritime – Excel version)

Attachment F: General Contact Investigation Outcome Reporting Form (Land)

Attachment G: TB Contact Investigation Outcome Reporting Form (Air)

Attachment H: TB Contact Investigation Outcome Reporting Form

(Maritime - word version)

Attachment I: TB Contact Investigation Outcome Reporting Form

(Maritime - Excel version)

Attachment J: Measles Contact Investigation Outcome Reporting Form (Air)

Attachment K: Measles Contact Investigation Outcome Reporting Form

(Maritime - word version)

Attachment L: Measles Contact Investigation Outcome Reporting Form

(Maritime - Excel version)

Attachment M: Rubella Contact Investigation Outcome Reporting Form (Air)

Attachment N: Rubella Contact Investigation Outcome Reporting Form

(Maritime - word version)

Attachment O: Rubella Contact Investigation Outcome Reporting Form

(Maritime - Excel version)

Attachment P: Ebola Airline Exposure Assessment Passenger Form

Attachment Q: Ebola Airline Exposure Assessment Flight Crew

Attachment R: Ebola Airline Exposure Assessment Cleaning Crew

Attachment S: Ebola Airline Exposure Assessment Airport or Other Port of Entry Staff

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Quarantine Station Illness Response Forms:
Author	aeo1
File Modified	0000-00-00
File Created	2021-01-27