1. Supporting Statement A_0920-1180_final

1. Supporting Statement A_0920-1180_final.docx

[NCEZID] Airline and Vessel and Traveler Information Collection (42 CFR Part 71)

OMB: 0920-1180

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Airline and Vessel Traveler Information Collection

(42 CFR Part 71)


(OMB Control No. 0920-1180)

Revision of a Currently Approved Collection


Submitted: June 02, 2023









Supporting Statement A




















Contact:

Thomas 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: qkh7@cdc.gov

Table of Contents



1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 3

3. Use of Improved Information Technology and Burden Reduction 3

4. Efforts to Identify Duplication and Use of Similar Information 4

5. Impact on Small Businesses or Other Small Entities 4

6. Consequences of Collecting the Information Less Frequently 4

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 4

9. Explanation of Any Payment or Gift to Respondents 4

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 5

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 5

12. Estimates of Annualized Burden Hours and Costs 5

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 6

14. Annualized Cost to the Government 6

15. Explanation for Program Changes or Adjustments 6

16. Plans for Tabulation and Publication and Project Time Schedule 6

17. Reason(s) Display of OMB Expiration Date is Inappropriate 7

18. Exceptions to Certification for Paperwork Reduction Act Submissions 7

Attachments 7





Shape1

Goal of the study: The goal of this information collection is to ensure that, consistent with the terms of regulations at 42 CFR 71.4 and 71.5, and the authorities in the Public Health Service Act and in the Code of Federal Regulations (CFR), CDC can collect conveyance, passenger and crew member contact information from airlines and maritime vessels in the event that there is a communicable disease risk associated with travelers coming to the United States and public health follow-up is needed. 



Intended use of the resulting data: The intended use of the information is to enable CDC to provide contact information to state and local health departments, in order to contact travelers in a timely manner to provide them with a notification that they may have been exposed to a communicable disease and to provide follow-up health information and any recommended interventions. 

  • Methods to be used to collect: There are no statistical sampling or research design methods being used.  CDC makes a determination of whether or not to collect manifest information depending on the risk of communicable disease spread during and after travel. 



The subpopulation to be studied: There is no subpopulation being studied. The universe of respondents is any airline or maritime company operating an airline or vessel aboard which an infectious or potentially infectious individual is confirmed to have traveled.



How data will be analyzed: Data will be analyzed to ensure that timely responses from airlines and vessels are received and that the manifest information is shared with state and local public health departments, who generally bear the responsibility of performing the contact investigations. However, there is no predetermined methodology to analyze the provision of manifest data from an airline or vessel. Passenger contact data will be analyzed to evaluate the completeness and validity of the information in order to provide feedback to airline and vessel partners.


  1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ) is requesting to revise the information collection request (ICR) titled (OMB Control No. 0920-1180, expiration date 06/30/2023) and obtain approval for a 3-year Paperwork Reduction Act (PRA) clearance. This information collection relates to CDC’s regulatory and public health mission to prevent the importation and spread of communicable disease. 42 Code of Federal Regulations part 71 outlines CDC’s authority related to the collection of passenger and crew manifest information from airlines and vessels, specifically when CDC identifies a risk of communicable disease spread to the United States from passenger or crew. This information collection request focuses on 42 CFR part 71 and is primarily concerned with flights arriving into the United States from international points of origin.

The rapid speed and tremendous volume of international travel, commerce, and human migration enable infectious disease threats to disperse worldwide in 24 hours - less time than the incubation period of most communicable diseases. These and other forces intrinsic to modern technology and ways of life favor the emergence of new communicable diseases and the reemergence or increased severity of known communicable diseases.

Stopping a communicable disease outbreak – whether it is naturally occurring or intentionally caused – requires the use of the most rapid and effective public health tools available. Basic public health practices, such as collaborating with airlines in the identification and notification of potentially exposed travelers, are critical tools in the fight against the introduction, transmission, and spread of communicable disease in the United States.

The collection of timely, accurate, and complete conveyance and traveler information enables CDC/DGMQ to notify state and local health departments in order for them to make contact with individuals who may have been exposed to a communicable disease during travel, or due to an outbreak of disease in a geographic location and identify appropriate next steps.

Section 361 of the Public Health Service Act (42 USC 264) (Attachment 1A) authorizes the Secretary of the Department 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, or from one State or possession into any other State or possession. Regulations that implement federal quarantine authority are currently promulgated in 42 CFR parts 70 and 71 (Attachments 1B & 1C). Part 71 contains regulations to prevent the introduction, transmission, and spread of communicable diseases into the states and possessions of the United States.

Specific provisions in the regulations at 42 CFR 71.4 and 42 CFR 71.5 clarify that CDC, as the federal public health authority, has explicit authority to require that airlines and ships provide to CDC, within 24 hours, specific PII and contact information on travelers to prevent the introduction and spread of disease into the United States and between the states and possessions. This collection is primarily concerned with airlines and international travelers. CDC currently carries out these same activities under broad general authority provided by 42 CFR 71.31 and 32 for both international air and maritime arrivals.

  1. Purpose and Use of Information Collection

Control of disease transmission within the United States is largely considered to be the province of State, Territorial and Local health authorities, with Federal assistance being sought by those authorities on a cooperative basis, without application of Federal regulations. The regulations at 42 CFR 71 were developed to facilitate Federal action in the event of ill or exposed travelers or deaths onboard arriving international flights. Any airline with a flight arriving into the United States, including any intermediate stops between the flight's origin and final destination, shall make certain data elements (provided below) available to the Director for passengers or crew who, as determined by the Director, may be at risk of exposure to a communicable disease, to the extent that such data are already available and maintained by the airline, within 24 hours of an order by the Director and in a format available and acceptable to both the airline and the Director.

CDC's current regulations at 42 CFR 71.4(a), (b), relating to the transmission of airline passenger, crew, and flight information for public health purposes, specify that airlines must provide certain information to CDC to the extent that such data are already available and maintained.

Airline or operator needs to retain this manifest information for 30 days after the flight’s departure unless the airline or operator has chosen to transmit the information securely to the U.S. Department of Homeland Security (DHS) via their established data systems. Data that has not already been transmitted to DHS must be transmitted to CDC within 24 hours upon request.



Passenger and crewmember manifests contain certain information for travelers on airlines and vessels and are generally collected from airlines and vessels after travel has been completed and when a disease is confirmed or there is a suspected exposure. Manifests include locating and contact information, as well as information concerning where passengers sat while aboard an airline or their location (e.g. cabin numbers) and activities aboard a vessel. The specific list of data elements included in 71.4(b) are:

  • Full name (last, first, and, if available, middle or others);

  • Date of birth;

  • Sex;

  • Country of residence;

  • If a passport is required; passport number, passport country of issuance, and passport expiration date;

  • If a travel document, other than a passport is required, travel document type, travel document number, travel document country of issuance and travel document expiration date;

  • Address while in the United States (number and street, city, state, and zip code), except that U.S. citizens and lawful permanent residents will provide address of permanent residence in the U.S.(number and street, city, state, and zip code; as applicable);

  • Primary contact phone number to include country code;

  • Secondary contact phone number to include country code;

  • Email address;

  • Airline name;

  • Flight number;

  • City of departure;

  • Departure date and time;

  • City of arrival;

  • Arrival date and time; and

  • Seat number for all passengers



CDC also requests seat configuration for the requested contact area (example: AB/aisle/CDE/aisle/FG, bulkhead in front of row 9), identification on the manifest of the crew and what zone crew were assigned to, the identification of any babes-in-arms, and finally CDC requests the total number of passengers on board if measles is the cause of the investigation, due to the highly infectious nature of the disease.

If there is a confirmed or suspected case of communicable disease aboard an airline or vessel, CDC submits an order under 42 CFR 71.4(a) and (b) and collects manifest information for those passengers or crew at risk for exposure. This type of manifest information collection differs in terms of the numbers of individual travelers depending on the communicable disease that is involved. CDC then uses this passenger and crew manifest information to coordinate with state and local health departments or International Health Regulation (IHR) National Focal Points (NFPs) so they can follow-up with residents who live or are currently located in their jurisdiction. In most cases, the manifests are issued for air travel and state and local health departments or IHR NFPs are responsible for the contact investigations; airlines and vessels may take responsibility for follow-up of crew members. In rare cases, CDC may use the manifest data to perform the contact investigation directly.



  1. Use of Improved Information Technology and Burden Reduction

In the event that a contact investigation is needed for confirmed or suspected exposures onboard, CDC sends the manifest orders via email. All submission of manifest information is accomplished in a secure manner, either via email or through a secure data exchange with Department of Homeland Security, Customs and Border Patrol platform.

  1. Efforts to Identify Duplication and Use of Similar Information

CDC has the regulatory authority for public health activities involving responses to illness and death aboard international and interstate flights and maritime voyages. This includes responding to a report of an ill traveler or death of a traveler on a conveyance, or when notified by the Department of Homeland Security (DHS) personnel at a port of entry. It also includes collecting contact and other information for passengers for public health follow-up and provision of data for communicable disease contact investigations. As a result, CDC is the only agency collecting manifest information from airlines and vessels for the purposes of communicable disease response.



CDC works in collaboration with its international, federal, state, and local partners at ports of entry to ensure all orders for manifests are performed in a coordinated manner and that the collection is limited to only the information needed to perform essential public health functions. CDC also relies on data collection systems managed by DHS that are already collecting several of the data elements from the airlines and maritime companies. CDC is not asking for the airlines and maritime companies to collect any additional information beyond what is currently collected using the manifest orders, only that what is collected and aligns with the listed data elements in 71.4 and 71.5 be provided within 24 hours of CDC’s request or transmitted to DHS for subsequent transmission to CDC. CDC needs to submit an order to the airlines first to confirm the individual identified as ill or exposed flew on the plane, and to ensure that CDC understands the configuration of the seats to appropriately determine which additional passengers are at risk. CDC can also confirm if any infants were traveling that might be at enhanced risk. Then, CDC leverages its partnership with federal partners to fill in the gaps in the contact information.



However, The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) issued Order: Requirement for Airlines and Operators to Collect Contact Information for All Passengers Arriving into the United States (Order) on October 25, 2021 requiring airlines and other aircraft operators to collect contact information for passengers before their arrival into the United States from a foreign country, retain the information for 30 days, and transmit the information to CDC upon request. The purpose of collecting this information is to identify and locate passengers who may have been exposed to a person with a communicable disease for public health follow-up.

Airlines and passenger-carrying operators are required to collect each passenger’s full name, address while in the United States, primary contact phone number, secondary or emergency contact phone number, and email address, to the extent this information exists, within 72 hours before the flight’s departure. All this aligns to the information from the manifest request, but when the airlines do not provide the timely updated information through this process, CDC needs to request a manifest as a stopgap to obtain the information required for public health actions. Similar to an order for a manifest, under this Order airlines and operators must maintain these data elements for crew members. Airlines and operators must also maintain, to the extent the data are already available and maintained by the airline, the following information for each passenger and crewmember:

  • date of birth

  • airline name

  • flight number

  • city of departure to the United States

  • departure date and time

  • city of arrival in the United States

  • arrival data and time

  • seat number


The airline or operator also needs to retain this information for 30 days after the flight’s departure unless the airline or operator has chosen to transmit the information securely to the U.S. Department of Homeland Security (DHS) via their established data systems. Data that has not already been transmitted to DHS must be transmitted to CDC within 24 hours upon request.

  1. Impact on Small Businesses or Other Small Entities

While some aviation, maritime, and other travel companies may be considered small businesses, CDC anticipates that the majority of the burden rests with larger passenger airlines given their volume of travelers. CDC has trimmed the required information collection to those minimally necessary to achieve public health objectives. Also, by making use of systems already available to airlines for the submission of this information, including established DHS systems, CDC anticipates that small carriers will not have to purchase equipment and/or incur programming expenses to comply with this information collection. Questions have been held for the absolute minimum required for the intended use of this information.

  1. Consequences of Collecting the Information Less Frequently

Timely information is needed from airlines in order to conduct contact investigations or implement other time sensitive public health interventions, such as administering prophylaxis. A reduction of required reporting would prevent CDC from meeting its statutory and public health mission, thereby endangering the public’s health.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. A 60-day Federal Register Notice was published in the Federal Register on April 27, 2023, vol. 88, No. 81, pp. 25640 (Attachment 2). CDC did not receive public comments related to this notice.

B. CDC communicates frequently with airlines and vessels when illness or death is confirmed to have occurred during a flight or maritime voyage. To attempt to streamline the process and work with airlines’ policies and procedures, CDC routinely complies with certain airlines’ requests to complete their proprietary data request form for each manifest.

  1. Explanation of Any Payment or Gift to Respondents

No payment is made to any respondent.

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

CDC’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does apply. A Privacy Impact Assessment is included as part of this submission (Attachment 3).

This information collection request has been reviewed by the National Center for Emerging and Zoonotic Infectious Diseases and it has been determined that the Privacy Act does apply to some aspects of this information collection request. The applicable System of Records Notice is 09-20-0171, Quarantine- and Traveler-Related Activities, including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71. Individual’s identifiable information will only be shared according to the Routine Uses described in the SORN, which are generally focused on providing public health authorities and cooperating medical providers with this information to assist in dealing with public health threats or for medical follow-up for a traveler.



Information submitted by the airlines and vessel is passed into a secure electronic database called the Quarantine Activity Reporting System (QARS). It is stored here for analysis, for processing to complete the passenger information data set, for swift dissemination to the state and local health departments through a secure CDC system called Epi-X (Epidemic Information Exchange), and for later retrieval if necessary. Electronic media will be protected by physical, administrative, and procedural safeguards to ensure the security of the data. Access to QARS is restricted to agency employees and contractors 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.

Further information concerning the protection of privacy can be found in the attached Privacy Impact Assessment (Attachment 3).



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

Institutional Review Board (IRB)

The protocols and tools used to conduct this information collection request have been reviewed and approved by NCEZID’s Human Subjects Advisor, who determined that this data collection does not meet the definition of research under 45 CFR 46.102(d).  IRB review is not required (Attachment 4 CDC Nonresearch Determination Letter).

Traveler contact information is ordered by CDC and submitted to CDC by the airline or vessel to prevent the spread of communicable diseases from foreign countries into the United States. Obtaining personally identifiable information, such as name, address, contact information, and travel document number, may be necessary during follow-up of potentially exposed passengers and crewmembers onboard. The information is only collected when it is required for public health purposes, and the information included in the order is the minimum necessary to meet statutory and public health obligations.

Justification for Sensitive Questions

There are no planned sensitive questions.

  1. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

Manifest orders are sent to airlines, and very rarely vessel operators (less than 10 times a year). CDC collects manifests for communicable diseases, e.g. tuberculosis, measles, mpox virus, pertussis, meningococcal disease and emerging/novel diseases such as COVID-19. CDC has developed a template manifest order to facilitate the collection of manifest information on international flights to the United States, the International Manifest Order Template (Attachment 5A).

CDC staff populate the order templates with available information when an individual is confirmed to have been infectious with a communicable disease during travel and uses the accompanying email template (Attachment 5B) and/or other airline requirement (e.g., Delta Manifest Request via their online request system or other forms from some other airlines with information for their specific processes) to notify the airline of the request. This information includes the nature of the communicable disease, flight itinerary information, the number and position of seats that should be submitted to CDC as manifest information, data elements requested for each traveler, and when the manifest information should be submitted to CDC. Airlines then follow their own protocols for reviewing the order and processing the manifest information to submit to CDC. CDC has no visibility on these processes; therefore, CDC is estimating the amount of time necessary to review the manifest order, look through their data systems, and provide the passenger manifest data to CDC. CDC estimates this activity could require between 1 and 4 hours per manifest search. We are including an average of 2.5 hours in this information collection request. We are including a 50/50 time split for airline respondent type, with equal time apportioned to an Airline Medical Officer or Equivalent and an analyst/travel specialist and manager. We are including equal time for each type of airline company respondent as CDC does not have knowledge of internal airline data search or submission practices.

In the event of an extremely pressing cases of infectious diseases, an informal manifest request may be sent to an airline (Attachment 5C) to give advanced notice to the airline to start pulling data, which is followed as soon as possible with the formal order. If the airline responds to the informal request prior to the formal order, CDC will follow up with a formal receipt of International Manifest Order (Attachment 5A) for the airline’s records.

The total staff hours used for this estimation correlate to the total hours required of CDC headquarters and Quarantine Station field staff to populate the manifest order template and email and send the order to the airlines, to validate the received manifest information with other sources of passenger information (i.e., CBP/National Targeting Center), to enter the received manifest information into QARS and validate all the data and distribute the information for the travelers in the risk exposure zone to the state health departments with jurisdiction. The breakdown in the following table is an outline of the number of hours required for each manifest order. The total is then multiplied by 350 to provide the total/burden per year for this activity.



Reviewing data in QARS related to manifest orders and accounting for increases in contact investigations associated with measles, TB and the mpox outbreak after COVID-19, CDC estimates that there are approximately 350 international manifest orders sent to airlines each year. We are providing an upper bound estimate for this information collection request to better anticipate sufficient burden to cover routine and response oriented manifest collections.

  • CDC is combining the request into one manifest order as the information needed for tuberculosis aligns with other infectious diseases and the time is estimated to be the same regardless of the disease (combining the estimated tuberculosis requests (51 from previous package) with the estimate of other infectious diseases (249 from previous package))

  • CDC is updating the time burden from 4-8 hours with an average of 6 to 1-4 hours with an average of 2.5 hours

  • CDC is increasing the estimated number of manifest orders from 300 to 350, but while the overall number of manifests is increasing the burden hours will be decreasing from 1800 hours to 875 hours due to updates in technology and processes the airlines potentially use to share the data that CDC is requesting.



Although the justification and need for vessel manifest orders is outlined above, CDC sends less than 10 manifest requests to vessel operators per year, so they are not accounted for in the burden table. The majority of the time, illness associated with cruise or maritime vessel travel occurs onboard, and no domestic contact investigation is necessary. CDC provides guidance to the vessels to prevent further spread of disease.

Type of Respondent

Form Name

No. of Respondents

No. Responses per Respondent

Avg. Burden per response (in hrs.)

Total Burden (in hrs.)

Airline Medical Officer or Equivalent/Analysis/Travel Specialist/Manager Equivalent

International Manifest Template/Informal Manifest Request Template


350

1

2.5

(150/60)

875

Total


875



B. Estimated Annualized Burden Costs

The cost to respondents was calculated using the May 2018 National Occupational Employment and Wage Estimates United States data from the Bureau of Labor Statistics (Department of Labor website). The total estimated respondent cost is $56,735.

Type of Respondent

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Airline Medical Officer or Equivalent/Analysis/Reservation/Travel Specialist Equivalent

International Manifest Template/Informal Manifest Request Template

875

64.84

$56.735

Total


$56,735


Respondents for this information collection include airline staff. The mean hourly wages for this category of respondent was calculated using occupation and wage statistics from the Bureau of Labor Statistics (BLS). Non-wage benefit adjustments provided below were sourced from BLS Employer Costs for Employee Compensation for civilian workers by occupational and industry group, available here: https://www.bls.gov/news.release/ecec.t02.htm


  • For Airline Medical Officer or Equivalent, we developed a weighted mean of 29-1171 Nurse Practitioners - $56.75 per hour (80%) and 29-1215 Family Medical Practitioners - $113.43 per hour (20%). This equals $68.09 per hour.


  • For Analyst/Reservation and Transportation Clerks we developed a weighted mean of 43-4181 Reservation and Transportation Ticket Agents and Travel Clerks - $21.94 per hour (70%) and 11-3012 Administrative Service Managers - $54.34 per hour (30%). This equals $31.66.

  • The average wage used to estimate respondent burden is ($68.09+$31.66)/2 = $49.88

  • CDC then adjusted this wage by 1.3 to account for non-wage benefits for a total hourly compensation of $64.84



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

CDC does not anticipate any cost additional burden to respondents under the manifest process as outlined in 42 CFR 71.4(a) and (b), as this only requires airlines to provide the information if it is available and maintained.

  1. Annualized Cost to the Government

For each manifest order issued in the event of a confirmed case, or suspicion of exposure, in a traveler or set of travelers after arrival in the United States, several CDC staff are involved in populating the manifest order, sending it to the airline, and reviewing and processing the manifest information and other sources of passenger contact information after manifest data has been received by CDC. In addition to staff time, the database QARS is used to organize the manifest information, and document and maintain all information received and shared with public health partners.

CDC estimates the yearly cost for this information collection request as a function of the staff time required to send, receive, process and distribute the passenger manifest information, and the pay level of the average CDC staff member performing these tasks.

The total staff hours used for this estimation correlate to the total hours required of CDC headquarters to populate the manifest order and email and send the order to the airlines, to validate the information received with additional sources of passenger information (i.e. Lexis Nexis, CPB/NTC), upload and validate the information into QARS, and distribute it to the state health departments with jurisdiction over where the at-risk travelers reside. In less than 5% of the most time sensitive/urgent cases and informal manifest order might be processes by Quarantine Station staff and sent to the airline station manager before the formal manifest order is sent to give the airlines advance notice that a timely/urgent manifest order is being sent. The total staff time also reflects technology and process improvements to decrease the burden and cost of the work. The breakdown in the following table is an outline of the number of hours required for each manifest order. The total is then multiplied by 350 to provide the total cost per year for this activity.

For average hourly wage, headquarters staff will complete the Formal Manifest Order and email (less than 5% of the time an Informal Manifest Order could be used and sent by QS staff before the Formal Manifest Order is sent) and send these documents to airline and then process and validate/verify all contact information provided, as well as information from additional sources as needed, to identify the best contact information for passengers in the exposure risk zone. NTC and CDC Liaison staff from DQMG at NTC will also process any additional NTC data requests, as needed, to find information when the airline has not provided contact information in the manifest information or to validate that foreign nationals have left the US and should be assigned to their home country for follow-up. Generally, the staff working on this process will be a GS12.

OPM wages used are from the Atlanta locality and are set at step one, and CDC adjusts the wage to account for total compensation by doubling the wage.


Time in hours required to perform activity in manifest collection

GS Level or Equivalent

Average hourly wage of staff reviewing data

Total Estimated Cost of Activity per Manifest Order

Complete Informal Manifest Request (only completed about 5% of the time)

.3

12

$41.91

$12.57

Complete Formal Manifest Order and collect appropriate data

.3

12

$41.91

$12.57

After receipt of initial manifest data, cleaning and validating data

1.5

12

$41.91

$62.87

Submission of NTC data request for additional identifiers via HSIN

.25

12

$41.91

$10.48

Fulfillment of NTC data request

2

12

$41.91

$83.82

Upon receipt of NTC data, validate/verify additional data in spreadsheet

.75

12

$41.91

$31.43

Upload and validate manifest information in QARS and distribute to states via Epi-X

.5

12

$41.91

$20.96

Total

5.6



$234.20



The total staff costs dedicated to the approximately 350 manifest orders per year is approximately $81, 970 per year. This is assessed by multiplying the 350 manifest orders by the total cost of processing one manifest, which is $234.20.

Staffing costs for the routine maintenance and development of QARS are also included. Annual costs for routine maintenance and development of QARS are approximately $250,000.

Total estimated annual cost for this information collection is $331,970.



  1. Explanation for Program Changes or Adjustments

CDC is requesting the following changes and adjustments in this revision.

Changes

International Informal Manifest Request Templates (TB and Non-TB):

  • Combined into one Manifest Request Template to align with current processes and needs


Adjustments

  • CDC is combining the manifest request into one manifest request and combining the estimates for tuberculosis and other infectious diseases into one estimate for manifest requests for all diseases because the estimated time and burden to complete the manifest request is estimated to be very similar for all diseases.

  • CDC is updating the time burden from 4-8 hours with an average of 6 to 1-4 hours with an average of 2.5 hours

  • CDC is adjusting the burden estimates for airlines based on general technology and process improvements that have resulted in data being more available in airline data bases and shared more readily with DHS/CBP, which is available to CDC on a shared data exchange and can be used to pull manifest order information more efficiently.

  • CDC is adjusting the cost estimates for the airlines based on technology and staffing updates about who is fulfilling the manifest orders.

  • CDC is adjusting the burden and cost estimates based on technology and process improvements at CDC/DGMQ and dedicated staffing to complete the process.

  • CDC is increasing the number of manifest orders from 300 to 350, due to other adjustments the burden hours have decreased by 925 burden hours. The adjusted total is 875 burden hours.






  1. Plans for Tabulation and Publication and Project Time Schedule

CDC may report aggregate totals of number of people screened, number of positives, and number of aircraft contacts publicly, as appropriate. Similarly, aggregate numbers of illness or death investigations may be reported.

Publication of the results of the public health risk assessment, and any lessons learned, may be published to inform future public health interventions and to contribute to the body of knowledge concerning public health interventions at ports of entry. No personally identifiable information will be published.

Project Time Schedule

Activity

Time Schedule

Use existing data, deidentified and aggregated, in a report on branch activities 2020-2022 for state, local, and territorial health departments as well as internal CDC leadership. Only descriptive statistics will be used

Compile data (June 2023- August 2023)

Prepare report (September 2023)

Review and clear report (October 2023)

Release report (November 2023)

Measles Summary 2007-2012

Finalizing publication September 2023

Measles Outbreak 2018-2019

Project Proposal submitted May 2023

Analysis finalized August 2023

Publication target November 2023

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

The display of the OMB Expiration date is not inappropriate.

  1. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

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

  2. Attachment 1B: 42 CFR Part 70

  3. Attachment 1C: 42 CFR Part 71

  4. Attachment 2: 60-day Federal Register Notice

  5. Attachment 3: Privacy Impact Statement_QARSAttachment

  6. Attachment 4: CDC Non-research determination_International Manifest

  7. Attachment 5A: International Manifest Order Template

  8. Attachment 5B: email template for International Manifest Order

  9. Attachment 5C: Informal International Manifest Order Template





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