0920-0134 Foreign Quarantine Reg SSA3.23.2022_final

0920-0134 Foreign Quarantine Reg SSA3.23.2022_final.docx

Foreign Quarantine Regulations (42CFR71)

OMB: 0920-0134

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International Travel: Illness and Death Reports for Foreign Quarantine Regulations (42 CFR 71)

(OMB Control No. 0920-0134)

Supporting Statement A

Request for Revision of an Approved Information Collection



March 23, 2022






















Contact:

Chip Daymude

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: 404.718.7103

Email: [email protected]





Contents







International Travel: Illness and Death Reports for Foreign Quarantine Regulations (42 CFR 71)

Statement in Support of Foreign Quarantine Regulations (42 CFR Part 71)

(OMB Control No. 0920-0134)


Shape1

Goal of the project: The goal of this information collection is to facilitate a CDC public health mission as provided under the Public Health Service Act and Code of Federal Regulations. As part of this revision, CDC is updating the Land Travel Illness and Death Investigation form, and moving information collections related to regulating importations of animals and human remains, and animal products to a new information collection request.


Intended use of the resulting data: CDC uses this information to meet its statutory and regulatory responsibilities outlined in 42 CFR part 71, which are to prevent the introduction of communicable disease into the United States and its territories.


Methods to be used to collect: No statistical methods are used. The information collection is intended solely to comply with statutory and regulatory responsibilities.

The subpopulation to be studied: There are no sub-populations to be analyzed. The universe of respondents is all individuals who seek to enter the United States, conveyance operators arriving to the United States, individuals who have been identified as ill during a flight or maritime voyage.


How the data will be analyzed: Data is analyzed to ensure compliance with CDC regulations and to determine if program enhancements or refocus is needed to meet the needs of public health in the United States.


























This is a request for a revision of a currently approved information collection request (ICR) that expires March 31, 2022. CDC is requesting a three-year OMB clearance for this information collection. The Centers for Disease Control and Prevention Division of Global Migration and Quarantine (DGMQ) is requesting approval for movement of information collection requests related to regulating importations of animals and human remains, and animal products to a new information collection request, and an update to the land travel illness and death investigation form. CDC is also continuing to pause the use of the Air Travel Illness or Death Investigation and Traveler Follow up Form in this information collection, since it is currently approved under OMB Control 0920-1318.



A. Justification

1. Circumstances Making the Collection of Information Necessary


Background

The purpose of this ICR is to request a revision of a currently approved information collection “Foreign Quarantine Regulationsthat expires March 31, 2022. Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264) (Attachment A1) 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. Statute and the existing regulations governing foreign quarantine activities (42 CFR 71) (Attachment A2) authorize quarantine officers and other personnel to inspect and undertake necessary control measures with respect to conveyances, and persons in order to protect the public’s health. Other inspection agencies, such as Customs and Border Protection (CBP), assist quarantine officers in public health screening of persons and make referrals to quarantine station staff when indicated. These practices and procedures ensure protection against the introduction and spread of communicable diseases into and within the United States with a minimum of recordkeeping and reporting procedures, as well as a minimum of interference with trade and travel.


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. 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 by conveyance operators or port partners (e.g. Customs and Border Protection), 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 a 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), DHS/CBP, and maritime partners such as ship medical personnel) 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 DGMQ and the Quarantine staff during the initial report of illness or death, and during the follow-up using the illness or death response forms, is entered into the Quarantine Activity Reporting System (QARS). QARS is a secure internet database implemented in June 2005 to document and track the illnesses and deaths reported to Quarantine Stations that occurred on conveyances entering the United States and at land border crossings.


CDC is making changes to the Land Border Illness or Death Investigation Form. CDC is pausing approval of the Air Travel Illness or Death Investigation Form in this information package, since it is currently approved under OMB Control 0920-1318 (re-titled Air Travel Illness or Death Investigation or Traveler Follow up Form). CDC will submit a request to move the Air Travel Illness or Death Investigation Form back in to this package, once it is appropriate to move it back into this package for OMB Control 0920-0134. CDC is not making changes to other information requests, but has updated the burden.


Previously this information collection also included information collections related to regulating importations of animals and human remains, and animal products. CDC plans to submit information collections related to importations into a new and separate information collection request.


The burden and respondent estimates provided in section A12 will reflect changes to burden.


2. Purpose and Use of Information Collection


The reporting, documentation and recordkeeping requirements contained in 42 CFR 71 regulations, and the air, maritime, and land border crossing illness or death reporting forms, are used by CDC to carry out quarantine and public health responsibilities as required by regulation and have been part of current practice for decades. This information collection from individuals, air and maritime conveyance operators, and importers is critical to CDC in fulfilling regulatory requirements that aim to reduce the risk that an infectious disease enters the United States in ill travelers or via contaminated or infected animals or other cargo.


The initial reports of illness outlined in 42 CFR 71.21(a) and (b) simply require notification to CDC that an individual has died during travel to the United States or that an individual has met the definition of “ill person” while en route to the United States. This definition is as follows:


Ill person means an individual:

(i) Who if onboard an aircraft:

(A) Has a fever (a measured temperature of 100.4 °F [38 °C] or greater, or feels warm to the touch, or gives a history of feeling feverish) accompanied by one or more of the following: Skin rash, difficulty breathing, persistent cough, decreased consciousness or confusion of recent onset, new unexplained bruising or bleeding (without previous injury), persistent diarrhea, persistent vomiting (other than air sickness), headache with stiff neck, appears obviously unwell; or

(B) Has a fever that has persisted for more than 48 hours; or

(C) Has symptoms or other indications of communicable disease, as the Director may announce through posting of a notice in the Federal Register.


(ii) Who if onboard a vessel:

(A) Has a fever (a measured temperature of 100.4 °F [38 °C] or greater; or feels warm to the touch; or gives a history of feeling feverish) accompanied by one or more of the following: Skin rash, difficulty breathing or suspected or confirmed pneumonia, persistent cough or cough with bloody sputum, decreased consciousness or confusion of recent onset, new unexplained bruising or bleeding (without previous injury), persistent vomiting (other than sea sickness), headache with stiff neck; or

(B) Has a fever that has persisted for more than 48 hours; or

(C) Has acute gastroenteritis, which means either diarrhea, defined as three or more episodes of loose stools in a 24-hour period or what is above normal for the individual, or vomiting accompanied by one or more of the following: One or more episodes of loose stools in a 24-hour period, abdominal cramps, headache, muscle aches, or fever (temperature of 100.4 °F [38 °C] or greater); or

(D) Has symptoms or other indications of communicable disease, as the Director may announce through posting of a notice in the Federal Register.


For routine response to illnesses associated with travel and reported to CDC, the purpose of these forms is to systematically collect information, thereby enabling Quarantine Station staff to assess, detect, and respond rapidly, 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 and follow-up purposes. The forms collect the following categories of information voluntarily: 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; severe acute respiratory syndromes; 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.


Information 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 CBP in the public health management of ill persons at U.S. ports and plan the appropriate response. Quarantine staff enter this data into QARS for analysis and retention in the event public health follow up is needed.


3. Use of Improved Information Technology and Burden Reduction


Reports of illness or death occurring on an aircraft are made to CDC electronically, per CDC and International Civil Aviation Organization guidelines (ICAO document 4444, Procedures for Air Navigation Services – Air Traffic Management, Ch.16, 16.6). Reports can be made via Air Traffic Control and the Domestic Events Network to the CDC Emergency Operations Center (EOC), or via the airline’s designated point of contact to the CDC Quarantine Station with jurisdiction for the arrival airport or CDC’s EOC.


Reports of illness or death from maritime conveyances are made electronically to [email protected].

4. Efforts to Identify Duplication and Use of Similar Information


CDC is the only public health authority with regulatory responsibility for collecting information on the occurrence of death or illness onboard air and maritime conveyances traveling to the United States. There is no duplication of collection in that regard.

5. Impact on Small Businesses or Other Small Entities

The collection of information does not primarily involve small entities. However, for the small entities involved, the burdens imposed by CDC’s information collection requirements are the minimum necessary for CDC to meet its regulatory and public health responsibilities.

6. Consequences of Collecting the Information Less Frequently

Further reduction of required and requested recordkeeping or reporting would prevent CDC from meeting it legislative mandate and regulatory responsibilities, and could therefore endanger the public’s health.

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

Information regarding the incidence of disease or death aboard maritime or air conveyances must also be reported on a real-time basis if it is to be used to prevent the importation and spread of disease into the United States. Depending on the situation, reporting may be verbal, written with no specific form specified, or written on the provided illness and death investigation forms with no extra copies required.

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


A. A notice to the public concerning CDC’s revision of this ICR was published in the Federal Register on January 7, 2022 (Vol. 87, No. 5, PP 977-979). CDC received one comment and has responded in Attachment C.


B. The requirements for notifying CDC of illness or death aboard air and maritime conveyances have been in place for decades, and in 2017 the definition of “ill person” for the purposes of reporting was updated as part of notice and comment rulemaking. CDC formulated the definition of ill person specifically to assist in making a public health determination if further action is necessary, and endeavored to align the signs and symptoms with the ICAO guidelines for reporting. Similarly, the illness or death investigation forms have been in use for many years and only include that information needed to determine if further public health action is needed. CDC routinely communicates with CBP and local EMS for traveler evaluations referencing these forms.

9. Explanations of Any Payment or Gift to Respondents

No monetary incentives or gifts are provided to respondents.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents.


There is no guarantee of confidentiality provided to respondents.


The applicable System of Records Notice (SORN) is 09-20-0171, Quarantine- and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71. CDC uses this notice for both people subject to the terms of the quarantine regulations. A Privacy Impact Assessment of this system is attached (Attachment G)

Personal identifiers (name, address, telephone number, cell number, etc.) will be collected and maintained under the Privacy Act system of records listed above from importers who are attempting to import certain animals and cargo into the United States and for individuals for whom an illness report is required according to 42 CFR 71.

Currently, illness/death information collected under this control number is entered into QARS by CDC staff during routine activities. Data containing personal identifiers and source documents, will be retained until the event prompting the collection of data has concluded in accordance with DGMQ’s records retention schedule.

Electronic media will be protected by adequate physical, administrative, and procedural safeguards to ensure the security of the data. Access will be restricted to agency employees with a bona fide “need to know” in order to carry out the duties of their positions or to accomplish the purposes for which the data were collected. When information is deleted, a special “certified” process will be used to completely overwrite tapes on the mainframe or overwriting (not merely deleting) microcomputer files. Source documents, printouts, and thumb drives will be safeguarded by storing them in locked cabinets in locked offices when not in use.


Information collected under this control number may be disclosed to appropriate State or local public health departments and cooperating medical authorities to deal with conditions of public health concern; to private contractors assisting CDC in analyzing and reviewing records; to investigators under certain limited circumstances to conduct further investigations; to organizations to carry out audits and reviews on behalf of HHS; to the Department of Justice for litigation purposes; and to a congressional office assisting individuals in obtaining their records. An accounting of the disclosures that have been made by CDC will be made available to the subject individual upon request. Except for these and other permissible disclosures expressly authorized by the Privacy Act, no other disclosure may be made without the subject individual’s written consent.



Highly sensitive information is being collected and would affect the security of a respondent’s personal identifying information if there were a breach of security. However, stringent safeguards are in place to ensure the security of a respondent’s personal identifying information 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 include 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 records 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 oversees compliance with these requirements.


Respondents to this data collection are generally aware that the information collected under this control number is required under regulation, and CDC publishes content on its website and in the Federal Register concerning these collections. For the information collected using the illness or death reporting forms, if an individual decides not to answer, the quarantine officer or partner cannot force them to answer. Only when a quarantine officer has a reasonable belief that a quarantinable communicable disease is present may an individual be detained to protect public health.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions


IRB Approval

NCEZID has reviewed the material for the Information Collection request and determined that it is Non-Research and IRB review is not required (Attachment H).


Sensitive Questions


This information collection requests certain personally identifying information of travelers. Some personally identifying information is required in illness reports in order to identify ill travelers. This information is necessary to engage in follow-up activities and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. As part of this information collection, CDC is not requiring or requesting the submission of any information related to criminal behavior, sexual behavior and attitudes, alcohol or drug use, religious beliefs, and other matters that are commonly considered private.

12. Estimates of Annualized Burden Hours and Costs


The burden imposed by this revision is based upon the estimated amount of time needed to perform each particular information submission multiplied by the number of responses to CDC. Under this revision, the total burden hours is estimated to be 3,595. This is significantly lower from the last revision estimate because it does not include information collections related to importation and it does not include estimates related to the Air Travel Illness and Death Investigation and Traveler Follow up Form because that is currently approved under 0920-1318. When the Air Travel Illness and Death Investigation and Traveler Follow up Form is put back into this information collection, the estimated annualized burden hours will increase.


Figures are based on estimates from Quarantine Staff activity at ports of entry. The estimates for each information collection are as follows:


  • 42 CFR 71.21(a) report of illness or death from ships – Maritime Conveyance Illness or Death Investigation Form sections 1-4

    • 500 respondents and 10 minutes per response for 83 total burden hours

  • 42 CFR 71.21(a) report of illness or death from ships – Maritime Conveyance Illness or Death Investigation Form section 5

    • 100 respondents and 5 minutes per response for 8 burden hours

  • Cumulative Influenza/Influenza-Like Illness (ILI) form

    • 3000 respondents and 2 minutes per response for 100 burden hours

  • 42 CFR 71.35 Report of death/illness during stay in port

    • Five respondents and 30 minutes each for three burden hours

  • 42 CFR 71.21 (b) Death/Illness reports from aircrafts

    • 79,500 respondents and 2 minutes per response for 2,650 burden hours. The number of Illness or Death Reports from aircrafts has increased significantly as a result of COVID-19. CDC expects this may be an overestimate, but prefers to overestimate at this time in the COVID-19 pandemic.

  • Land Travel Illness or Death Investigation Form

    • 3000 respondents and 15 minutes per response for 750 burden hours

  • 42 CFR 71.33 Report by persons in isolation or surveillance

    • Eleven respondents and three minutes per response for one burden hour











Estimated Annualized Burden (Hours)

Type of Respondents

Form Name

No. of Respondents

No. of Responses per Respondent

Average Burden per Response (in hours)

Total Burden Hours

Maritime Vessel Operator

42 CFR 71.21(a) report of illness or death from ships –

Maritime Conveyance Illness or Death Investigation Form Sections 1-4 (Attachment D)

500

1

10/60

83

Maritime Vessel Operator

42 CFR 71.21(a) report of illness or death from ships –

Maritime Conveyance Illness or Death Investigation Form Section 5 (Attachment D)

100

1

5/60

8

Maritime Vessel Operator

Cumulative Influenza/Influenza-Like Illness (ILI) (Attachment E)

3000

1

2/60

100

Maritime Vessel Operator

42 CFR 71.35 Report of death/illness during stay in port (No Form)

5

1

30/60

3

Pilot in command

42 CFR 71.21 (b) Death/Illness reports from aircrafts (No form)

79,500

1

2/60

2,650

Traveler

Land Travel Illness or Death Investigation Form (Attachment F)

3,000

1

15/60

750

Isolated or Quarantined individuals

42 CFR 71.33 Report by persons in isolation or surveillance (No Form)

11

1

3/60

1

Total





3,595



12 B. Estimates of Annualized Cost

Respondents for this information collection include airline maritime conveyance operators, importers/filers, and the general public. Average wages for each category of respondent were calculated using occupation and wage statistics from the Bureau of Labor Statistics. Total estimated cost for these information collections is $266,774.73. When the Air Travel Illness and Death Investigation and Traveler Follow up Form is put back into this information collection, the estimated annualized cost will increase.


  • For Maritime Vessel Operators 53-5021 Captains, Mates, and Pilots of Water Vessels is used.  This yields an average of $43.14 per hour. (53-5021 Captains, Mates, and Pilots of Water Vessels: http://www.bls.gov/oes/current/oes535021.htm.)

  • For pilots in command, 53-2011 Airline Pilots, Copilots, and Flight Engineers (http://www.bls.gov/oes/current/oes532011.htm) was used, with an average hourly wage of $89.84

  • For the isolated or quarantined individuals, the general public occupational category is used. The hourly wage for this occupational category is $27.07. (00-0000 All Occupations: http://www.bls.gov/oes/current/oes_nat.htm#00-0000)

  • For importers, the general public occupational category is used as no BLS category was available for importers/filers or a similar occupation. The average wage is $27.07 ( 00-0000 All Occupations: http://www.bls.gov/oes/current/oes_nat.htm#00-0000)




Type of Respondents

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Maritime Vessel Operator

42 CFR 71.21(a) report of illness or death from ships –

Maritime Conveyance Illness or Death Investigation Form Sections 1-4 (Attachment D)

83

$43.14

$3,580.62

Maritime Vessel Operator

42 CFR 71.21(a) report of illness or death from ships –

Maritime Conveyance Illness or Death Investigation Form Section 5 (Attachment D)

8

$43.14

$345.12

Maritime Vessel Operator

Cumulative Influenza/Influenza-Like Illness (ILI) (Attachment E)

100

$43.14

$4,314.00

Maritime Vessel Operator

42 CFR 71.35 Report of death/illness during stay in port (No Form)

3

$43.14

$129.42

Pilot in command

42 CFR 71.21 (b) Death/Illness reports from aircrafts (No form)

2,650

$89.84

$238,076.00

Traveler

Land Travel Illness or Death Investigation Form (Attachment F)

750

$27.07

$20,302.50

Isolated or Quarantined individuals

42 CFR 71.33 Report by persons in isolation or surveillance (No Form)

1

$27.07

$27.07

Total




$266,774.73




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

There are no other costs to respondents or record keepers.

14. Annualized Cost to the Government


For each report of illness in travelers covered by 42 CFR part 71, Quarantine staff collect and review the information to determine whether a public health response is necessary. Their actions are determined by the statutory and regulatory requirements for each report, and the time required to appropriately respond varies. The amount of time to respond depends on the specifics of the report, requiring action such as filing and/or data entry to conducting an investigation involving multiple staff.


The total staff time is estimated by totaling the number of death or illness reports received by CDC and multiplying it by the average time it takes to receive and process the initial report. This is then multiplied by a GS12 level wage at the Atlanta locality.



Time in hours required to review and collect initial incoming data

Average hourly wage of staff reviewing data (GS12 Atlanta locality adjustment)

Total Estimated Yearly Cost

Radio, hard copy, verbal reports

86,005 reports x .5 hours (30 min)

$45.48

$1,956,000


There are also CDC system and personnel costs associated with the use, development, and maintenance of QARS. These costs include the IT staffing costs and associated SME staffing costs. The QARS related costs dedicated only to international reports of communicable disease or death cannot be separated from the total QARS system costs; therefore, the total QARS costs are presented here. These costs are as follows:


QARS System Costs

$190,000

Staff Costs (Atlanta locality adjustment):

1xGS-12 and 1xGS-9(75%)

$140,375

Total

$330,375


The total estimated cost to the government for this ICR is approximately $2,616,750 per year, however this is expected to be an overestimate since the number of illness and death reports may be high due to the COVID-19 pandemic and costs for international reports can’t be separated out in QARS,

15. Explanation for Program Changes or Adjustments

CDC has made the following changes to this information collection:

  • Removed information collection requests related to regulating importations of animals and human remains, and animal products to a new information collection request.

  • CDC has updated the Land Travel Illness or Death Investigation Form to incorporate updates related to COVID-19 and to provide more specificity on location of the ill traveler

    • A section to allow for recording COVID-19 vaccination status details, such as date of doses, type of vaccine manufacturer, etc.

    • The option to record loss of taste or smell

    • The option to indicate when an ill traveler is located at a port of entry as a pedestrian or in vehicle. This is unique to land border illness reporting.

  • The annualized burden hour and cost estimates are significantly lower than last estimates, going from 268,493 to 3,595 burden hours and from $6,540,311.34 to $266,774.73 annualized cost estimates. This is because the estimates related to importation have been moved to another information collection request just related to importation, and the estimates related to the Air Travel Illness or Death Investigation and Traveler Follow up Form are currently approved under OMB Control 0920-1318. When the Air Travel Illness or Death Investigation and Traveler Follow up Form is moved back into this information collection, the estimates will increase.



Schedule

Data are not collected for statistical purposes, but only to meet the regulatory mandate as implemented in the foreign quarantine regulations found at 42 CFR 71.

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

The display of the expiration data is not inappropriate. CDC requests no exemption.

18. Exceptions for Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

List of Attachments

Attachment A1 - Section 361 Public Health Service Act (42 USC 264)

Attachment A2 - 42 Code of Federal Regulations part 71

Attachment B - 30 Day Federal Register Notice

Attachment C – Responses to Public Comment from 60 Day Federal Register Notice

Attachment D- Maritime Conveyance Illness or Death Investigation Form

Attachment E - Maritime Conveyance Cumulative Influenza or Influenza-Like Illness (ILI) Form

Attachment F - Land Travel Illness or Death Investigation Form

Attachment G - Privacy Impact Assessment

Attachment H - IRB Non-Research Determination





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