0821 Illness Response Forms Renewal Part A 6_27_12

Quarantine Station Illness Response Forms:

Airline, Maritime, and Land/Border Crossing

(0920-0821 expires 9/30/2012)

Request for OMB Approval of a Revision for an Existing Information

Collection Request

June 25, 2012

Contact:

Amy McMillan

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 D76

Atlanta, Georgia 30333

Phone: (404) 639-4895

Fax: (404) 248-4146

Email: [email protected]

Quarantine Station Illness Response Forms:

Airline, Maritime, and Land/Border Crossing

Request for OMB Approval of a Revision for an Existing Collection Request

CDC is requesting OMB approval for a revision of existing data collection for 0920-0821 Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing. This information collection request is currently approved for a total of 439 burden hours as a result of a 2010 OMB approval for a non-substantive change.

CDC is requesting minor changes to the content and format of the illness response forms. These changes will result in a decrease in burden to the individual respondents due to improved form organization and clarity. Subsequent to this change, CDC is requesting a lesser number of hours, 377, to collect data under 0920-0821.

A. Justification

1. Circumstances making the Collection of Information Necessary

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 domestic and foreign quarantine regulations; 42 CFR Parts 70 and 71 (Attachment B). 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, i.e. any infectious agent known or suspected to cause disease in humans, in order to protect the public’s health. 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 regulation:

• 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 presence of a suspected case of a communicable disease on a domestic flight should be reported to the local health authority.

The 2003 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 has continued to work with aviation partners to update this recommended reporting guidance. The result of these consultations is a revised set of observable conditions that CDC thinks more fully encompasses the range of potential conditions indicating a communicable disease of public health concern (Attachment D).

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 E).

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 F). 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 or from one State or possession to another State or possession. 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. 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, Quarantine Station staff need to systematically interview ill travelers and collect relevant health and epidemiologic information.

When Quarantine Officers are present at the port of entry, they may often respond in person to conduct assessment of an ill traveler. However, 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 without causing substantial delays to travel. 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, whether in-person, by phone, or through a trained responder (in consultation with the Quarantine Officer).

Data collected by Quarantine Station staff using the illness response forms are entered into the Quarantine Activity Reporting System (QARS). QARS is a secure internet database implemented in June 2005 to track the number of illnesses and deaths reported to Quarantine Stations that occurred on conveyances entering the United States and at land border crossings. In addition, QARS is used to record 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 regulated by CDC, and emergency releases of drugs and immunobiologics controlled by CDC (artesunate; botulism, diphtheria and tetanus antitoxins).

The recent modifications to the illness response forms have:

• Improved the grouping of related questions into more clearly defined sections, which should speed up data collection while increasing data quality

• Removed questions that are less important to the response to illness or death to reduce public burden

• Reformatted and combined select questions to streamline data collection

• Clarified select section titles and questions to better communicate the intent of the data collection

• Maintained a uniform flow of data collection across all three forms(air, maritime and land border)

• Standardized vocabulary so that phrasing of questions is consistent across all forms

• Modified some wording to align verbiage with correct operational terms

• Added small number of questions to improve the relevance of the specific data collected by CDC staff for illness or death response

• Slightly modified the format to reduce length of form

This recent change is providing a more efficient reporting process for conducting surveillance for illnesses and deaths among travelers. The modifications to the forms make searching through QARS information for specific data elements easier and faster. The overall result is an enhanced ability to monitor illness and conduct investigations of infectious diseases in travelers that maintains a balance between protecting public health and limiting the burden of data collection on the public.

Privacy Impact Assessment

These data are being collected to fulfill regulatory requirements under 42 CFR Parts 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 except in de-identified or aggregate formats.

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 of records 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 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.

Overview of the Data Collection System

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

It is not always necessary to obtain complete epidemiologic information from every ill traveler; therefore, a 2-tiered approach has been used in the development of these forms – Info Only and Response reports. 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 Info Only responses.

Response reports require obtaining full epidemiologic information from the ill traveler. Quarantine Station staff will use the entire form to collect information and will follow up with the ill traveler.

This tiered approach to data collection during illness investigations 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 does not involve web-based collection methods; however, data are entered into a web-accessible database, QARS. Only authorized CDC staff have access to the data system and no cookies are used. The privacy policy and rules of conduct are provided and adhered to when staff enter or view data, or request a data set from QARS. The web-accessible data 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 into and within 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: identifying and contact information, demographics, 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 concern 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. These data are then entered into QARS.

Privacy Impact Assessment

These data are being collected to fulfill regulatory requirements under 42 CFR Part 70 and 71. 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 except in de-identified or aggregate formats.

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 of records 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 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.

3. Use of Improved Information Technology and Burden Reduction

As stated in the previous submission, the data needed to complete the illness forms are 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 duration of travel and to prevent delays for travelers, there is often 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 or deceased person. These data are then entered into QARS. 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 the Quarantine Station with jurisdiction over the next port of entry via secure fax or email. CDC has implemented a secure 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 and improve data security.

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 illnesses or deaths on conveyances or at land borders are reported to Quarantine Stations at ports 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 illnesses or deaths on conveyances or at land borders are reported to Quarantine Stations at ports 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 Monday, April 23, 2012 (Vol. 77, No. 78, p. 24210) (Attachment J) announcing the proposed data collection and requesting public comment. CDC received no public comment on this data collection.

B. CDC is the primary authority with responsibility to prevent the introduction and spread of communicable disease in the U.S. through air, land and sea ports of entry. No other entity collects the type and quantity of information from ill travelers that is specified in the attached investigation forms. While the respondents to this data collection are individual travelers, not industry, CDC does work with the air and cruise industries on the information collection process outlined in this Supporting Statement to ensure that these industries are able to operate with the least interference possible, while also maintaining the ability to collect the information needed to protect public health.

9. Explanation of Any Payment or Gift to Respondents

There is no payment or gift to respondents

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. This information is collected under the Privacy Act system of records 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 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.

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 voluntary nature of their response. The Privacy Act advisement also addresses the voluntary nature of the response. If an illness of public health concern is suspected based on the information collected using these forms, the individual in question may be required to undergo further assessment and questioning.

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) identifying and contact information such as name, passport number, telephone number, address 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 into and within 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. CDC is requesting a total number of burden hours based on the number of illnesses reported to QARS in 2009. CDC is basing the request on 2009 statistics because they include the increased number of influenza-like illness reports from the 2009 influenza A (H1N1) pandemic. The increase in 2009, while not necessarily reflected in reports of disease from subsequent years gives the Division of Global Migration and Quarantine flexibility to collect data during unexpected increases in rates of disease within the approval of the 0920-0821 information collection. DGMQ therefore estimates that the number of respondents will be approximately 3,758 for this revision; the same estimated number of respondents previously approved in the October 2010 Notice of Action.

The estimated time to complete the forms for an ill traveler is approximately 5 minutes for the air and land border forms and 7 minutes for the maritime form. The amount of time depends on if a response is warranted and the availability of 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 377 hours. Assuming an hourly respondent labor wage of $21.35 for the general public the estimated annual cost to respondents would total $8,050 (http://www.bls.gov/oes/current/oes_nat.htm#00-0000).

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

A. Estimate of Total Burden Hours

Form	Number of Respondents (2009, incl. H1N1)	Number of Responses per Respondent	Average Burden per Response (in minutes)	Total Burden Hours
Airline Travel Illness or Death Investigation Form	1626	1	5/60	136
Maritime Conveyance Illness or Death Investigation Form	1873	1	7/60	219
Land Travel Illness or Death Investigation Form	259	1	5/60	22
Total	3,758			377

B. Estimate of Annualized Cost to Respondents

Form	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Airline Travel Illness or Death Investigation Form	136	$21.35	$2,904,
Maritime Conveyance Illness or Death Investigation Form*	219	$21.35	$4,676
Land Travel Illness or Death Investigation Form	22	$21.35	$470
Total	377	$21.35	$8,050

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 $13398.20. 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:

Respondents:

Respondents Interviewed per year 3,758

Staff Time 6 minutes

Hourly rate $29

Subtotal – investigations $10,898.20

Other costs – printing $2,500.000

Total annual costs: $13398.20

15. Explanation for Program Changes or Adjustments

CDC is requesting minor changes to the content and format of the illness response forms to improve the efficiency and usefulness of the data collected under 0920-0821. These changes will result in a decrease in burden to the individual respondents due to improved form organization and clarity of questions. Subsequent to this revision, CDC is requesting a lesser number of hours: 377.

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 ill travelers or death reports from conveyances or at land border crossings are received by Quarantine Stations at ports of entry. Reports are generated three times a week and monthly using QARS data. In addition, DGMQ plans to use the de-identified, aggregated data, to provide partners and other stakeholders information about CDC’s illness response activities and to evaluate and improve CDC’s activities at ports of entry.

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

Expiration date display exemption does not apply to Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

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

Attachment B: 42 CFR Parts 70 and 71

Attachment C: 2009 Recommended Reporting Guidance

Attachment D: Revised Recommended Reporting Guidance

Attachment E: Attachment E – 42 CFR Part 71.31 Subpart D

Attachment F: Quarantine Station Jurisdiction Map

Attachment G: Air Travel Illness or Death Investigation Form

Attachment H: Maritime Conveyance Illness or Death Investigation Form

Attachment I: Land Travel Illness or Death Investigation Form

Attachment J: 60 Day Notice

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