NEWQ Station Illness Forms Supporting Statement - Jan2009 rev 04 24 09

NEWQ Station Illness Forms Supporting Statement - Jan2009 rev 04 24 09.doc

Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing

OMB: 0920-0821

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Quarantine Station Illness Response Forms:

Airline, Maritime, and Land/Border Crossing



Request for OMB Approval of a New Information Collection Request


December, 2008






Contact:

Anne O’Connor

National Center for Preparedness, Control, and Detection of Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS C-12

Atlanta, Georgia 30333

Phone: (404) 639-1042

Fax: (404) 639-3039

Email: [email protected]





Quarantine Station Illness Response Forms:

Airline, Maritime, and Land/Border Crossing


Request for OMB Approval of a New Information Collection Request


A. Justification


1. Circumstances making the Collection of Information Necessary


This is a request for approval of a new information collection request that supports Quarantine staff responsibilities of assessing, detection and responding to reports of communicable disease threats of potential public health importance at U.S. ports of entry. CDC is requesting a three year approval to collect data.


Section 361 of the Public Health Service (PHS) Act (42 USC 264) (Attachment A) 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, the Division of Global Migration and Quarantine (DGMQ) works to fulfill this responsibility through a variety of activities, including the operation of Quarantine Stations at ports of entry and administration of foreign quarantine regulations; 42 CFR Part 71. These regulations authorize quarantine officers and other personnel to inspect and undertake necessary control measures with respect to conveyances (e.g., airplanes, cruise and cargo ships), persons, and shipments of animals and etiologic agents in order to protect the public’s health (Attachment B). The regulations also require conveyances to immediately report an “ill person” or any death on board to the Quarantine Station prior to arrival in the United States. An “ill person” is defined by statute:

    • Fever (≥100º F or 38º C) persisting ≥48 hours

    • Fever (≥100º F or 38º C) AND rash, glandular swelling, or jaundice

    • Diarrhea (≥3 stools in 24 hours or greater than normal amount)

The SARS outbreak and concern about pandemic influenza as well as other communicable diseases have prompted CDC to recommend that all communicable illnesses that meet specified criteria be reported to Quarantine Stations prior to arrival (Attachment C).


CDC works with its partners in the Department of Homeland Security, specifically Customs and Border Protection (CBP), to identify ill travelers1. Under Part 71, Subpart D-Health Measures at US Ports: Communicable Diseases, CDC can detain and assess a carrier (defined as a ship, aircraft, train, road vehicle, or other means of transport, including military) if it is determined that failure to inspect will present a threat of introduction of communicable diseases into the United States (Attachment D).


U.S. Quarantine Stations are located at 20 ports of entry and land-border crossings where international travelers arrive. The jurisdiction of each Station includes air, maritime, and/or land-border ports of entry (Attachment E). DGMQ’s Quarantine Station staff, i.e., Quarantine Officers, work in partnership with international, federal, state, and local agencies and organizations to fulfill their mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, and other globally mobile populations. This work is performed to prevent the introduction, transmission, and spread of communicable diseases from foreign countries into the United States. When an illness suggestive of a communicable disease is reported, Quarantine Officers respond to carry out an onsite public health assessment and collect data from the individual. This response may occur jointly with port partners. If Quarantine Officers are unable to respond in-person, they provide phone consultation to port partners (e.g., Emergency Medical Services (EMS), CBP Officers, and maritime partners) on the scene, to determine the public health importance of the illness. In both circumstances, an interview of the ill person(s) is required to conduct the public health assessment.


There are many instances in which a Quarantine Officer may not be able to meet a conveyance or border crosser in person, including (but not limited to) the following: the conveyance arrives at a port of entry that does not have Quarantine station on site; a maritime vessel is still out at sea when the report comes in; Quarantine Officers are already responding to another illness report; or the illness may be reported after hours and Quarantine Officers cannot arrive in time to meet the conveyance or border crosser. The collection of comprehensive, pertinent public health information during these responses enables Quarantine Officers to make an accurate public health assessment and identify appropriate next steps. For this reason, the Quarantine Station staff whether in-person, via phone, or through a trained responder (in consultation with the Quarantine Officer) need to systematically interview the ill traveler and collect relevant health and epidemiologic information.

Privacy Impact Assessment

This data is being collected to fulfill regulatory requirements under 42 CFR Part 70 and 71. The data will be used by CDC to prevent the introduction or spread of communicable disease into the United States or from one State or possession to another State or possession. The data will not be shared.


Highly sensitive information is being collected and would affect a respondent’s privacy if there were a breach of confidentiality. This information is collected under the Privacy Act system notice 09200171, “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 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 media 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.


Overview of the Data Collection System


Quarantine Stations have developed illness response forms for the three different types of ports of entry – air, maritime, and land/border. The forms are also used by Quarantine Station staff to collect information for follow-up and tracking (surveillance) purposes. These forms include 1) the Air Travel Illness or Death Investigation Form, 2) a two-part maritime form: the International Maritime Illness or Death Report Form and the International Maritime Illness or Death Investigation Form, 3) the Land Border Illness or Death Investigation Form. All three types of forms collect pertinent demographic, clinical and epidemiologic information on travelers who are suspected of being infected with a communicable disease, and may be (or may have been) contagious during travel. The differences between the forms reflect the unique public health risks associated with specific modes of travel and how illness are responded to at each of the three types of ports (Attachment F).


It is not always necessary to obtain complete epidemiologic information from every ill passenger; therefore, a 3-tiered approach has been used in the development of these forms. When Quarantine Station staff respond to a situation that is not of public health interest (e.g., chronic skin condition, heart attack, etc.) only general information is collected. This information includes: contact information, date and complaint. These non-public health interest situations are referred to as Tier One responses.


Both Tier Two and Tier Three responses require obtaining full epidemiologic information from the ill passenger. Tier Two responses involve a person who is possibly ill with a disease of public health interest without formal diagnosis (e.g., fever + rash). Quarantine Station staff will use the entire form to collect information and will follow up with the ill passenger. Tier Three response involve a person with a diagnosed disease of public health interest (e.g., tuberculosis, measles, etc.). Again, Quarantine Station staff will use the entire form to collect information and will follow up with the ill passenger.


This tiered approach will reduce the burden on the public by collecting only information appropriate for the situation.


Items of Information to be Collected


This data collection includes the following information in identifiable form: medical information and notes, name, date of birth, mailing address, phone numbers, country of birth, passport number, alien number, legal status, and visa type.


Identification of website


This data collection involves web-based collection methods. Only authorized CDC staff have access to the data system and no cookies are used. The privacy policy and rules of conduct are provided when staff request a data set. The system is not directed to children under 13 years of age.


2. Purpose and Use of Information Collection


The information collected on the forms enables Quarantine Station staff 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.


The purpose of the illness response forms is to systematically collect information, thereby enabling Quarantine Station staff to assess, detect and respond efficiently and accurately to communicable disease threats of potential public health importance 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 and mode of transportation, pertinent clinical and medical history, epidemiologic history, other relevant facts (e.g., travel history, traveling companions, etc.), and information specific to the traveler’s conveyance or mode of travel. This information is used by Quarantine Station staff to identify specific signs and symptoms common to the nine quarantinable diseases (Pandemic influenza; SARS; Cholera; Plague; Diphtheria; Infectious Tuberculosis; Smallpox; Yellow fever; and Viral Hemorrhagic Fevers), as well as other communicable diseases or conditions of public health interest, which may be transmissible in a conveyance setting.


Data collected on these forms are used by Quarantine Station staff to make decisions about a traveler’s suspected illness as well as its communicability. This information enables Quarantine Station personnel 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 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 both 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, diphtheria and malaria anti-toxins).


Privacy Impact Assessment


This data is being collected to fulfill regulatory requirements under 42 CFR Part 70. The data will be used by CDC to prevent the spread of communicable disease from one State or possession to another State or possession. The data will not be shared.


Highly sensitive information is being collected and would affect a respondent’s privacy if there were a breach of confidentiality. 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 information needed to complete the illness forms is collected by either Quarantine staff (in-person, fax, email or phone), conveyance staff (e.g., ship agents) or other trained responders (e.g., EMS) in consultation with Quarantine Station staff. Due to the limited length of travel and to prevent delays for travelers, there is only a short window of opportunity to collect data on illnesses and deaths as well as information on those persons who may have been exposed to the ill person. In the future, CDC is planning to put the illness response forms on PDA/PC tablets for Quarantine Station staff so data can be collected in a paperless form, thus increasing the efficiency and validity of the data and minimizing errors due to information transfer. In circumstances where Quarantine staff are unable to meet the conveyance or border crosser in person, the ill persons will either be interviewed directly by phone or through an intermediary, such as trained port partners (e.g., EMS, DHS) or state and local public health professionals. For maritime vessels, public health reports are typically received and investigations carried out while the vessel is still at sea. Therefore, in addition to the phone, ship staff often times complete the forms and transmit data to their designated Quarantine Station via secure fax or email. CDC is developing an electronic reporting system for maritime vessels to report illness or death aboard a conveyance, thus reducing the amount of time needed for these conveyances to transmit data.


4. Efforts to Identify Duplication and Use of Similar Information


As noted previously, CDC has the regulatory authority for performing quarantine-related activities at U.S. ports of entry (42 Part 71). This includes responding to a report of an ill traveler or death of a traveler on a conveyance or when requested by Department of Homeland Security personnel at a land border crossing. As a result, CDC is the only agency collecting illness or death reports related to the introduction and transmission of communicable diseases at ports of entry. In addition, CDC works in collaboration with its international, federal, state, and local partners at ports of entry to ensure all illness responses are done in a coordinated manner.


5. Impact on Small Businesses or Other Small Entities


Some of the respondents may be considered small businesses. However, data collection variables are kept to an absolute minimum to minimize burden on small businesses.



6. Consequences of Collecting the Information Less Frequently


The frequency of data collection is determined by the frequency that an illness or death on a conveyance is reported to a Quarantine Station at a port of entry. Control of communicable diseases or conditions of public health interest is dependent on rapid identification and immediate response when identified. If data are not collected immediately, there is a risk of introduction and spread of disease to the U.S. public. There are no legal obstacles to reducing the burden.


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


Frequency of data collection is inconsistent with the guidelines, as discussed in Section A6. The frequency of data collection is determined by the frequency that an illness or death on a conveyance is reported to a Quarantine Station at a port of entry; this could occur more often than quarterly.


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


A. A notice was published in the Federal Register on April 15, 2008 (Vol. 73, No. 73, pp. 20293-20294) (Attachment G) announcing the proposed data collection and requesting public comment. One comment was received from the public. A copy of the comment and CDC’s response are found in Attachment L.


B. On March 16, 2007, CDC met with several major cruise line staff and CLIA (Cruise Lines International Association), the cruise industry’s main lobbying and marketing association. The meeting was held to review CDC quarantine stations’ authority, responsibility, and process for receiving and investigating reports of illnesses suggestive of a communicable disease based on 42 CFR Part 71. The meeting also provided an opportunity to address the cruise industry’s major concerns regarding reporting and investigation mechanisms. CDC provide the attendees with guidance documents on reporting criteria as well as the draft maritime report/investigation form.


CLIA and industry representatives provided the following feedback:

  1. The CDC reporting process should be electronic (not paper-based) utilizing the existing CDC VSP system, so that cruise lines can use one electronic system to report to CDC; and

  2. The investigation form should be streamlined and be as illness-specific as possible;

  3. The data collection should have the capability of electronic transmission to quarantine stations via a password protected website.

The attendees were invited to provide detailed feedback on the investigation form and assist CDC in developing the next draft of the form. This meeting was preceded and followed by at least 2 teleconferences with CLIA and cruise line staff to discuss issues surrounding reporting and investigation. As a result of all meetings, the existing report/investigation form has been broken down into two forms. The first form, called the International Maritime Conveyance Report form, will be made electronic in the existing CDC Vessel Sanitation Program (VSP) electronic system. The second form, called the International Maritime Conveyance Investigation form has been made shorter, with exclusion of the specific information about contacts and inclusion of skip areas for situation or illness specific questions.


Contact information for CLIA:

Mr. Michael Crye, President

Cruise Lines International Association

910 SE 17th Street, Suite 400

Fort Lauderdale, FL 33316

phone: 754-224-2200

fax: 754-220-2250


Representative from cruise lines:


Dr. Carlos Gonzalez, M.D. Vincent Warger, Director

Medical Consultant Loss Prevention & Medical Services

Royal Caribbean Cruise Lines Royal Caribbean Cruise Lines

3160 SW 189th Terrace 3160 SW 189th Terrace

Miramar, FL 33029 Miramar, FL 33029

Office: 305-490-5444 Office: 305-539-6016

Fax: 954-538-9648 Fax: 305-213-3885


Steve Williams Dr. Jabez Steencamp

Director of Medical Operations

Carnival Cruise Lines Carnival Cruise Lines

3655 NW 87th Avenue 3655 NW 87th Avenue

Miami, FL 33178 Miami, FL 33178

Office: 305-599-2600, x18009 Office: 305-599-2600


Dr. Ben Shore Dr. Grant Tarline

Medical Consultant Medical Consultant

Norwegian Cruise Line Princess Cruise Lines

7665 Corporate Center Drive 24844 Avenue Rockefeller

Miami, FL 33126 Santa Clarita, CA 91355

Office: 305-436-4952 Office: 1-661-753-2600

Fax: 305-436-4159



9. Explanation of Any Payment or Gift to Respondents

Not applicable.


10. Assurance of Confidentiality Provided to Respondents


Privacy Impact Assessment Information


A. The CDC Information Collection Request Office (ICRO) has reviewed this application and determined that the Privacy Act is applicable. Names or other personal identifying information are routinely collected by CDC on case reports. Where applicable, these forms are maintained as a system of records under the Privacy Act system notice 09200171, “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 information collected from travelers will be kept confidential, and will not be disclosed to anyone unless necessary to carry out their regulatory responsibilities or as otherwise required by law.


B. Highly sensitive information is being collected and would affect a respondent’s privacy if there were a breach of confidentiality. 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.


C. Respondents initiate the data collection process. Respondents are informed about the intended use of the information collection and plans for sharing the information via the Privacy Act advisement at the bottom of the form.


D. Respondents are informed about the mandatory nature of their response. The Privacy Act advisement also addresses the mandatory nature of the response.


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) contact information such as telephone number, address, passport number for follow-up or contact tracing. 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


Quarantine Stations have implemented practices and procedures that balance the health and safety of the American public with the public’s desire for minimal interference with travel and trade. Whenever possible, Quarantine Station staff obtain information about the ill traveler from other documentation (e.g., customs declarations, passport, or other documents) to reduce the amount of the public burden. Based on the actual number of illnesses reported to QARS in 2007 and recognizing that rates of reporting will likely increase in the future, DGMQ estimates that the number of respondents will be approximately 1,580. The estimated time to complete the forms for an ill traveler is approximately six minutes for the air and land border forms and 10 minutes (total) for the two maritime forms. The amount of time depends on the severity of the case, the number of contacts, and whether Quarantine Station staff versus other medical authorities is collecting the information. In a majority of the cases, within the first few minutes, a Quarantine Officer can collect all relevant information from or about the ill traveler and determine whether there is a risk of a communicable disease threat and how much additional information needs to be collected. The total burden hours would therefore be approximately 172 hours. Assuming an hourly respondent labor wage of $17.75 for the general public (www.bls.gov/news.release/empsit.t17.htm) the estimated annual cost to respondents would total $3,053.


The estimated annualized burden hours (Table A) is based upon completion of an entire form.


A. Estimate of Annualized Burden Hours and Costs

Form

Number of Respondents

Number of Responses per

Respondent

Average Burden per Response

(in hours)

Total Burden Hours

Airline Illness or Death Investigation Form

1320

1

6/60

132

International Maritime Illness or Death Report


200

1

3/60

10

International Maritime Illness or Death Investigation Form

200

(same as above)

1

7/60

24

Land Border Illness or Death Investigation Form

60

1

6/60

6

Total

1580



172


B. Estimate of Annualized Cost to Respondents


Form

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Airline Illness or Death Investigation Form

132

$17.75

$2,343.00

International Maritime Illness or Death Report

10

$17.75

$177.50

International Maritime Illness or Death Investigation Form

24

$17.75

$426.00

Land Border Illness or Death Investigation Form

6

$17.75

$106.50

Total

172


$3,053.00


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


There are no capital and maintenance costs incurred by respondents.


14. Annualized Cost to the Government


The annual cost to the federal government is estimated at $271,101.90. This estimate represents the amount of time for the staff at the Quarantine Stations, as well our maritime partners to complete the forms and input them into QARS, in addition to the costs of printing the forms.


Breakdown of costs:


Investigations:

Investigations per year 1,315

Time to respond 7 minutes

Hourly rate $29

. Subtotal – investigations $268,601.90


Other costs – printing $2,500.000


Total annual costs: $271,101.90



15. Explanation for Program Changes or Adjustments


This is a new data collection.


16. Plans for Tabulation and Publication and Project Time Schedule


These are recurring data collections, the time schedules for which are determined by the frequency that an ill traveler or death report from a conveyance or at a land border crossing is received by a Quarantine Station. Both daily and monthly reports are generated for CDC staff using QARS data. There are also plans to start generating weekly reports. In addition, Quarantine officers 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 CDC’s illness response activities and to evaluate and improve CDC’s these activities at ports of entry.


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


CDC requests an exemption to the expiration date display on the illness response forms (Attachments H-K). The information collected on these forms is routine and will not change except to update the expiration each time the package is renewed. The forms will be distributed to each Quarantine Station for use by Quarantine Station staff.


18. Exceptions to Certification for Paperwork Reduction Act Submissions


There are no exceptions to the certification.



B. Collections of Information Employing Statistical Methods


No statistical methods are used in this data collection.


U.S. Quarantine Stations are located at 20 ports of entry and land-border crossings where international travelers arrive. The jurisdiction of each Station includes air, maritime, and/or land-border ports of entry (Attachment E). Quarantine Station staff work in partnership with international, federal, state, and local agencies and organizations to fulfill their mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, and other globally mobile populations. This work is performed to prevent the introduction, transmission, and spread of communicable diseases from foreign countries into the United States. When an illness suggestive of a communicable disease is reported, Quarantine Officers respond to carry out an onsite public health assessment and collect data from the individual. This response may occur jointly with port partners. If Quarantine Officers are unable to respond in-person, they provide phone consultation to port partners (e.g., Emergency Medical Services (EMS), CBP Officers, and maritime partners) on the scene, to determine the public health importance of the illness. In both circumstances, an interview of the ill person(s) is required to conduct the public health assessment.


There are many instances in which a Quarantine Officer may not be able to meet a conveyance or border crosser in person, including (but not limited to) the following: the conveyance arrives at a port of entry that does not have Quarantine station on site; a maritime vessel is still out at sea when the report comes in; Quarantine Officers are already responding to another illness report; or the illness may be reported after hours and Quarantine Officers cannot arrive in time to meet the conveyance or border crosser. The collection of comprehensive, pertinent public health information during these responses enables Quarantine Officers to make an accurate public health assessment and identify appropriate next steps. For this reason, the Quarantine Station staff whether in-person, via phone, or through a trained responder (in consultation with the Quarantine Officer) need to systematically interview the ill traveler and collect relevant health and epidemiologic information.


Quarantine Stations have developed illness response forms for the three different types of ports of entry – air, maritime, and land/border. The forms are also used to collect information for follow-up and tracking (surveillance) purposes. These forms include 1) the Air Travel Illness or Death Investigation Form, 2) a two-part maritime form: the International Maritime Illness or Death Report Form and the International Maritime Illness or Death Investigation Form, 3) the Land Border Illness or Death Investigation Form. All three types of forms collect pertinent demographic, clinical and epidemiologic information on travelers who are suspected of being infected with a communicable disease, and may be (or may have been) contagious during travel. The differences between the forms reflect the unique public health risks associated with specific modes of travel and how illness are responded to at each of the three types of ports (Attachment F).


It is not always necessary to obtain complete epidemiologic information from every ill passenger; therefore, a 3-tiered approach has been used in the development of these forms. When Quarantine Station staff respond to a situation that is not of public health interest (e.g., chronic skin condition, heart attack, etc.) only general information is collected. This information includes: contact information, date and complaint. These non-public health interest situations are referred to as Tier One responses.


Both Tier Two and Tier Three responses require obtaining full epidemiologic information from the ill passenger. Tier Two responses involve a person who is possibly ill with a disease of public health interest without formal diagnosis (e.g., fever + rash). Quarantine Station staff will use the entire form to collect information and will follow up with the ill passenger. Tier Three response involve a person with a diagnosed disease of public health interest (e.g., tuberculosis, measles, etc.). Again, Quarantine Station staff will use the entire form to collect information and will follow up with the ill passenger.


This tiered approach will reduce the burden on the public by collecting only information appropriate for the situation.


Attachments


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


Attachment B: 42 CFR Part 71


Attachment C: Criteria for Ill Person Reporting (Aviation)


Attachment D: Part 71, Subpart D-Health Measures at US Ports: Communicable Diseases


Attachment E: Map of Quarantine Station Jurisdictions


Attachment F: Summaries of Response Forms



Attachment G: 60 day Federal Register Notice



Attachment H: Air Travel Illness or Death Investigation Form



Attachment I: Maritime Illness or Death Report



Attachment J: Maritime Illness or Death Investigation Form



Attachment K: Land Border Illness or Death Investigation Form


Attachment L: Public Comment and CDC’s response





16


File Typeapplication/msword
File TitleQuarantine Station Illness Response Forms:
Authoraeo1
Last Modified Byshari steinberg
File Modified2009-04-29
File Created2009-04-29

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