0920-1180_INTL Manifest Supporting Statement Part A_06022020

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 Code of Federal Regulations (CFR), CDC can collect conveyance, passenger and crew member contact information in the event that there is a communicable disease risk associated with travelers coming to the United States.
The intended use of the information is to enable CDC to provide contact information to state and local health departments, so they can 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. In limited circumstances, CDC may contact travelers directly.
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.
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.
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.

(OMB Control No. 0920-1180)

This revision is requesting minor changes to the verbiage of the international manifest order forms to clarify the data required by CDC to conduct a contact investigation and to provide general grammatical improvements to enhance clarity. The number of estimated international manifests ordered from the air carriers in response to a confirmed case or suspected exposure after arrival is increased given CDC’s experience with the 2019 measles outbreak and the current novel coronavirus (COVID-19) outbreak.

A. Justification

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 05/31/2020) 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 microbial 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. The current outbreak of COVID-19 is evidence of this reality.

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 Quarantine Officers in CDC’s 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 (Attachment 1B) and 71 (Attachment 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.

2. Purpose and Use of Information Collection

Control of disease transmission within the United States is largely considered to be the province of State 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.

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.

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) is:

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.

In the event that 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 so they can follow-up with residents who live or are currently located in their jurisdiction. In the vast majority of cases, the manifests are issued for air travel and state and local health departments 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.

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.

3. 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 or fax. Some airlines have specific forms that they require CDC to complete and submit along with the order; for example, the International Air Transport Association (IATA) Request Form for Passenger Contact Tracing. All submission of manifest information is accomplished in a secure manner, either via email or fax.

4. 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. 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 than we currently collect using the manifest orders, only that what is collected and what aligns with the listed data elements in 71.4 and 71.5 be provided within 24 hours of CDC’s request. 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.

5. 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.

6. Consequences of Collecting the Information Less Frequently

Given the scope of the outbreak of COVID-19, and the concurrent presence of other communicable diseases (e.g., measles, tuberculosis, meningitis, rubella) identified in airline travelers, CDC needs this data on a routine basis. Further reduction of required reporting would prevent CDC from meeting its statutory and public health mission, thereby endangering the public’s health.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. A 60-day Federal Register Notice (Attachment 2A) was published in the Federal Register on December 23, 2019, Vol 84, No 246, p70549. CDC three comments (Attachment 2B-2D).

Comment

CDC received two sets of comments from air industry groups commenting that at the time the Interim Final Rule was published, CDC’s Paperwork Reduction Act Federal Register Notice, published December 23, 2019, was not reflective of the burden associated with the revised information collection requirements.

CDC Response

We received comments pointing to the substantive change in CDC’s information collection request submission between the 60- and 30-day comment periods. We believe that comments on this point are valid, as OMB guidance directs that there should not be substantive changes to information collection requests outside of responses to comment between the two public comment periods under the PRA. CDC is amending this ICR to restrict it to only request what was both in the 60 and 30 day notices. CDC will seek approval from OMB to implement the additional request separately. The estimates of burden pertain to the routine collection as previously approved by OMB under this information collection request, updated only for increased estimated numbers of manifest orders on annual basis.

Comment

CDC also received a comment from industry concerning methodology and assumptions use to make the following assertions. Of the issues still pertinent in the comment after CDC’s acknowledgement of the commenter’s valid concerns stated above, the following two issues remain relevant:

1) “CDC does not anticipate any cost 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.”7

2) For Form “International Non-TB Manifest Template”

Number of respondents – 249
Average burden per response (in hours) – 360/60

CDC Response

1) As stated in the regulation at 42 CFR 71.4(a),(b) airlines are only required to send information to CDC in response to an manifest order to the extent the information is available and maintained. This is not a requirement for new or more information. And so CDC does not anticipate any cost burden to respondents under the manifest process as outlined in 42 CFR 71.4(a) and (b).

2) As stated in Supporting Statement A section 12, this estimate is sourced from tracking contact investigations involving manifest orders sent to airlines, this data is stored in CDC’s Quarantine Activity Reporting System. The number may be increased to reflect additional estimated burden if it is reasonable to assume that there might be a change in the number of anticipated contact investigations in a given year, e.g. ongoing outbreaks, or rounded up for administrative efficiency due to an inability to predict with any accuracy the number of potential contact investigations in any one year. This estimate has varied widely between initial drafting and the current version as the number of contact investigations have continued to increase due to the COVID-19 pandemic. The proportion of manifests ordered for TB vs non-TB has also changed, primarily due to measles and COVID-19 investigations. The initial estimate provided in the 60-day Federal Register Notice included 49 non-TB manifest orders, as that was the approximate number of manifests issued in the previous year for diseases other than TB. CDC has performed more than 200 contact investigations on arriving international flights in 2020 alone, exemplifying the difficulty in predicting the number of manifests that will be issued in any one year.

1Jan-27Apr2020 Air CIs--All Diseases
Row Labels	Count of Inbound
International Inbound	211

CDC sought comment on this estimate as we do not have insight into air carrier processes for gathering and providing the data. CDC did not receive comment on the burden associated with this information collection in previous solicitations of public comment in 2020 and 2016.

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. CDC is also considering the adoption of the International Air Transport Association data request form. CDC makes every attempt to ensure that the collection of manifest information is not an undue burden on the respondents.

No specific consultations regarding manifest requests have occurred with maritime vessel operators, because vessel manifest requests are very rare.

9. Explanation of Any Payment or Gift to Respondents

No payment is made to any respondent.

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

This information collection request has been reviewed by the CDC National Center for Emerging and Zoonotic Diseases (NCEZID). NCEZID has determined that the Privacy Act does apply to this information collection request. The applicable System of Records Notice is 09-20-0171. 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 (Attachments 3A and 3B).

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

IRB Approval

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).

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.

12. Estimates of Annualized Burden Hours and Costs

Manifest orders are sent to airlines, and very rarely vessel operators (less than 10 times a year) and are most often the result of confirmed cases of infectious tuberculosis in individuals who traveled on an airline. However, CDC also collects manifests for other communicable diseases, e.g. pertussis, measles, and meningococcal disease. Because there are fewer communicable disease incidents when manifests are ordered for these other communicable diseases, CDC has developed two template letters to facilitate the collection of manifest information on international flights to the United States. The templates are as follows:

International TB Manifest Template Order (Attachment 5)
International Non-TB Manifest Template Order (Attachment 6)

CDC staff populate the order templates and an accompanying cover letter (Attachment 7) and/or other airline requirement (e.g., International Air Transport Association Request Form for Passenger Contact Tracing (Attachment 8)) with information that is available when an individual is confirmed to have a communicable disease that was infectious during travel. 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 4 and 8 hours per manifest search. We are including an average of 6 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 a Computer and Information Systems 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 that advanced notice to the airline is needed in extremely pressing cases of infectious diseases, an informal manifest request template (Attachment 9 and 10) is sent, 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 manifest letter (Attachment 11) 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 develop the manifest order template and cover letter and send the order to the airlines, to enter the received manifest information into QARS, to compare the received manifest information with other sources of passenger information (i.e., CBP/National Center), and then to compile the manifest information and distribute it to the state health departments with jurisdiction over where the at-risk travelers reside. 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 300 to provide the total cost per year for this activity.

Reviewing data in QARS related to manifest orders and accounting for increases in contact investigations associated with measles and COVID-19, CDC estimates that there are approximately 300 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 reducing the number of manifest orders associated with tuberculosis from 67 to 51, for a reduction of 96 burden hours. The adjusted total is 306 burden hours.
CDC is increasing the number of manifest orders associated with other infectious disease from 29 to 249, an increase of 1,320 burden hours. The adjusted total is 1,494 burden hours.

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 vast majority of the time, illness reports 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.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Airline Medical Officer or Equivalent/ Computer and Information Systems Manager	International TB Manifest Template/Informal Manifest Request Template	51	1	360/60	306
Airline Medical Officer or Equivalent/ Computer and Information Systems Manager	International Non-TB Manifest Template/Information Manifest Request Template	249	1	360/60	1494
Total					1,800‬

B. 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 (http://www.bls.gov/oes/current/oes_nat.htm). The total estimated respondent cost is $159,336.‬‬‬‬

Estimated Annualized Burden Costs

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Airline Medical Officer or Equivalent/ Computer and Information Systems Manager	International TB Manifest Template/Informal Manifest Request Template	306	$88.52	$27,087‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
Airline Medical Officer or Equivalent/ Computer and Information Systems Manager	International Non-TB Manifest Template. /Informal Manifest Request Template	1494	$88.52	$132,249
Total				$ 159,336‬‬‬‬‬

Respondents for this information collection include travelers and 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 average of 29-1171 Nurse Practitioners - $52.90 per hour (80%) and 29-1062 Family and General Practitioners - $101.82 per hour (20%). This equals $62.68 per hour.
For Computer and Information Systems Manager we used 11-3021 Computer and Information Systems Managers, with a mean hourly wage of $73.49.
The average wage used to estimate respondent burden is ($62.68+$73.49)/2 = $68.09
CDC then adjusted this wage by 1.3 to account for non-wage benefits for a total hourly compensation of $88.52

13. 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.

14. 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 developing the template, sending it to the airline, and reviewing and processing the manifest after it has been received at CDC. In addition to staff time, the database QARS is used to organize the manifest data, and document and provide context for the manifest order.

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 and Quarantine Station field staff to develop the manifest order template and cover letter and send the order to the airlines, to enter the received manifest information into QARS, to compare the received manifest information with other sources of passenger information (i.e. CBP/NTC), and then to compile the manifest information and distribute it to the state health departments with jurisdiction over where the at-risk travelers reside. 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 100 to provide the total cost per year for this activity.

For average hourly wage, depending on the Quarantine Station with jurisdiction for where the flight arrived with the confirmed death or illness, different staff will complete the Informal Manifest Request, and Formal Manifest Order and Cover Letter, and send these documents to airline. Generally, the staff will either be a GS9 or GS13 depending on the staff compliment at the station, with GS9s being more likely to complete these tasks. Therefore, we have used a weighted average of 60% for GS9 and 40% for GS13. The individuals who manage the manifest through the process at NTC and sending the data to the states are generally at the GS13 level.

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	.5	9 or 13	$68.90	$34.45
Complete Formal Manifest Order and Cover Letter and send to airline	1	9 or 13	$68.90	$68.90
After receipt of initial manifest data, creation of NTC spreadsheet	1.5	13	$92.12	$138.18
Submission of NTC data request for additional identifiers via HSIN	.25	13	$92.12	$23.03
Fulfillment of NTC data request	4	13	$92.12	$368.48
Upon receipt of NTC data, clean/verify additional data in spreadsheet	1.5	13	$92.12	$138.18‬
Compile the manifest information and distribute to states via Epi-X	.75	13	$92.12	$69.09
Total	9.5			$840.31

The total staff costs dedicated to the approximately 300 manifest orders per year is approximately $252,093 (rounded) per year. This is assessed by multiplying the 300 manifest orders by the total cost of processing one manifest, which is $840.31.

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 $502,093

15. Explanation of 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):

Added: Insert name of index case – the existing template did not ask for the name of the ill passenger (index case).
Grammar corrections throughout document for clarity.

International TB Manifest Order Template:

Added: Insert name of index case – the existing template did not ask for the name of the ill passenger (index case).
Grammar corrections throughout document for clarity.

International Non-TB Manifest Order Template:

Added: Insert name of index case – the existing template did not ask for the name of the ill passenger (index case).
Added request for flight attendants and pilots – this is a recent revision to the protocol, new to this template.
Added request to identify crew on manifest – this is a recent revision to the protocol, new to this template.
Grammar corrections throughout the document for clarity.

Adjustments

CDC is reducing the number of manifest orders associated with tuberculosis from 67 to 51, for a reduction of 96 burden hours. The adjusted total is 306 burden hours.
CDC is increasing the number of manifest orders associated with other infectious disease from 29 to 249, an increase of 1,320 burden hours. The adjusted total is 1,494 burden hours.

The net increase in burden hours associated with this information collection request is 1,224 hours.

16. Plans for Tabulation and Publication and Project Time Schedule

Data are not collected for statistical purposes, but only to meet the regulatory and public health mandate as outlined in 42 CFR part 71.

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

No exemption is requested.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

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

Attachment 1B: 42 CFR Part 71

Attachment 1C: 42 CFR Part 70

Attachment 1D: Interim Final Rule 42 CFR 71.4(d)

Attachment 1E: February 18, 2020 Order under 42 CFR 71.31 and 71.4

Attachment 2A: 60-day Federal Register Notice

Attachment 2B: Public comment

Attachment 2C: Public comment

Attachment 2D: Public comment

Attachment 3A: QARS Privacy Impact Assessment

Attachment 3B: Epi-X Privacy Impact Assessment

Attachment 4: CDC Non-research determination

Attachment 5: International TB Manifest Template Order

Attachment 6: International Non-TB Manifest Template Order

Attachment 7: Order Cover Letter

Attachment 8: IATA Passenger Manifest Information Request Form Contact Tracing

Attachment 9: Informal manifest request template TB

Attachment 10: Informal manifest request template non-TB

Attachment 11: Receipt of manifest letter

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0920-1180_INTL Manifest Supporting Statement Part A_06022020