0920-0900 SupSta A_FINAL_081924
0920-0900 SupSta A_FINAL_081924.docx
[NCEZID] Contact Investigation Outcome Reporting Forms
OMB: 0920-0900
Contact Investigation Outcome Reporting Forms
(OMB Control No. 0920-0900)
Expires 08/31/2024
Request for Revision of a Currently Approved Data Collection
July 11, 2024
Supporting Statement A
Contact:
Rudith Vice
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404) 718-7292
Email: [email protected]
Table of Contents
1. Circumstances Making the Collection of Information Necessary 3
2. Purpose and Use of Information Collection 4
3. Use of Improved Information Technology and Burden Reduction 4
4. Efforts to Identify Duplication and Use of Similar Information 5
5. Impact on Small Businesses or Other Small Entities 5
6. Consequences of Collecting the Information Less Frequently 5
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 5
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 6
9. Explanation of Any Payment or Gift to Respondents 6
10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 6
11. Institutional Review Board (IRB) and Justification for Sensitive Questions 6
12. Estimates of Annualized Burden Hours and Costs 6
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 8
14. Annualized Cost to the Government 9
15. Explanation for Program Changes or Adjustments 10
16. Plans for Tabulation and Publication and Project Time Schedule 10
17. Reason(s) Display of OMB Expiration Date is Inappropriate 12
18. Exceptions to Certification for Paperwork Reduction Act Submissions 12
The goal of this
information collection is to obtain sufficient information on the
results of contact investigations carried out by state, local, and
territorial public health professionals or maritime medical crews
to assess the impact of a potential or confirmed communicable
disease of public health concern in a traveler, both in terms of
further transmission of disease, health outcomes for cases and
contacts, and to determine if further public health intervention is
appropriate.
The information will be used
to assist and collaborate with state, local, and territorial health
departments, conveyance operators, port of entry partners, and
international public health authorities to identify potential
exposures and to determine the risk of infection and whether future
public health interventions are needed. Methods to be used to collect
information are basic surveys of respondents that record
information about the exposed traveler’s location and
activities on air or maritime conveyance or land border crossing,
other potential exposures, signs/symptoms that may occur after
their potential exposure, prior history of vaccination or disease,
and other medical conditions that could influence the risk of
infection or severity of illness. Surveys may take the form of
fillable PDF or a secure online survey such as CDC REDCap. The
questions and data collected will not differ between the two survey
types. The respondent universe is
state, local, or territorial public health officials and airline,
maritime, or land conveyance operators who assist CDC by conducting
contact tracing of potentially exposed travelers within their
jurisdiction or on maritime conveyances, or among airline or ship
crew members. No statistical methods will be
used in this information collection. Data may subsequently be
analyzed to estimate communicable disease transmission risk on
conveyances.
This is a request for revision to a currently approved information collection, OMB Control No 0920-0900, Contact Investigation Outcome Reporting Forms. CDC is requesting a three-year approval for the contact investigation outcome reporting information collection tools to continue the CDC’s routine contact investigation activities. These collections enable CDC to better assess the risk to individuals who may have been exposed to a potential or confirmed case of a communicable disease of concern while traveling to or within the United States.
CDC is requesting changes to some of the forms in use under this control number, primarily the air travel-related contact investigation outcome reporting forms (TB, measles, rubella, and general). The changes are being requested to improve the quality and public health relevance of the information collected and reduce the burden on health departments.
Section 361 of the Public Health Service (PHS) Act (42 USC 264) (Attachment A.1) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. Under its delegated authority, CDC works to fulfill this responsibility through a variety of activities, including the operation of port health stations at ports of entry and administration of foreign and interstate quarantine regulations; 42 CFR Parts 70 and 71 (Attachment A2 and A3), respectively. These regulations require conveyances to immediately report an ill person or any death to the port health station of jurisdiction prior to arrival in the United States.
CDC’s activities with regard to communicable diseases and travel generally occur sequentially. When an illness or death suggestive of a communicable disease is reported during travel (reported under OMB Control Number 0920-0134 Foreign Quarantine Regulations by airlines or Customs and Border Protection for international travelers arriving to the United States; or OMB Control Number 0920-0488 Restrictions on Interstate Travel of Persons for interstate flights) port health protection officers or our port partners respond to carry out an onsite public health assessment and collect pertinent information using “Illness Response and Investigation Forms,” OMB Control Number 0920-0134. In other cases, CDC is notified via other channels after travel by public health departments that a person was ill and infectious during their flight or maritime voyage, or land border crossing. The public health response may differ depending upon the assessment of the ill or deceased person. One such response is determining that travelers need to be notified if they were exposed to the communicable disease during travel. This notification of travelers is critical for the timely implementation of public health measures to mitigate or prevent further spread of communicable diseases.
After CDC has collected the flight or maritime vessel manifest information, CDC is then responsible for providing state, local, and territorial public health authorities with adequate contact information, such as phone numbers and addresses included in manifests, to facilitate successful notification of the exposed travelers. CDC sends this information to the state or territorial health department via Epi-X (a secure public health messaging system) or via secure email to the maritime vessels. It is typically the responsibility of state, local, or territorial health departments or maritime operators to contact exposed travelers. The extent of the conveyance contact investigation is determined by which travelers are believed to have been exposed to a communicable disease and is based on CDC investigative protocols. The success of preventing the spread of a communicable disease on air or maritime conveyances is due in large part to the effectiveness of the CDC’s investigative protocols and the provision of contact information. CDC’s ability to control the spread of communicable disease through implementing effective investigative protocols is impaired without comprehensive feedback on the outcome of the notification and contact investigation conducted by state, local, and territorial health departments or from maritime conveyance operators after the investigation has concluded.
The information collected on the outcome reporting forms by state, local, and territorial health departments and maritime operators enables CDC to more fully understand the extent of disease transmission during travel. This information assists in the development and/or refinement of investigative protocols, aimed at reducing the spread of communicable disease.
The purpose of the proposed contact investigation outcome reporting forms is to uniformly collect information from state, local, and territorial health department officials as well as maritime operators conducting contact investigations on behalf of CDC. This information enables CDC to assess, detect, and respond efficiently and accurately to communicable disease threats of potential public health concern 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: demographics, pertinent clinical and medical history, and epidemiologic and travel history.
This information enables CDC staff to assist conveyances and border agents in the public health management of ill persons at U.S. ports and plan the appropriate response. This data is then entered into the Port Health Activity Reporting System (PHARS), a secure web-based, data-management system used by all CDC Port Health Stations to record information about the daily activities of port health station staff.
Use of Improved Information Technology and Burden Reduction
The majority of responses (outcome reporting forms) are submitted using secure e-mail, fax, or Excel spreadsheets (maritime forms only). Surveys are currently offered as a fillable PDF; once the revised forms included in this ICR package are approved they will also be offered through a secure online survey using CDC REDCap. The questions and data collected will not differ between the two survey types.
Efforts to Identify Duplication and Use of Similar Information
CDC retains the regulatory authority for performing quarantine-related activities at U.S. ports of entry (42 CFR part 71) and related to interstate travel (42 CFR part 70). One such activity is providing pertinent traveler information to state, local, and territorial health departments and maritime operators for the notification of those who may have been exposed to a communicable disease during travel. CDC is the only agency that provides this information, and the health department of jurisdiction or maritime operator is the main entity that conducts the contact investigations. In addition, CDC works in collaboration with its international, federal, state, local, and territorial partners to ensure all contact investigations associated with communicable disease exposure during travel are done in a coordinated manner. There is no duplication of data regarding the outcome of contact investigations initiated by the CDC for international or interstate travelers.
Due to the COVID-19 pandemic, CDC Port Health Stations no longer receive cumulative Influenza-like-Illness (ILI) reports from cruise ships, which were previously under this OMB control number (0920-0900) through the Influenza Like Illness Investigation Outcome Reporting Form. In December 2023, CDC developed a surveillance system for cumulative acute respiratory illness (ARI) reports from international cruise ship voyages whose itinerary includes at least one U.S. port (OMB Control Number 0920–1335). ARI is caused by SARS-CoV-2 (the virus that causes COVID-19), influenza virus, or respiratory syncytial virus (RSV). Within this Cumulative ARI Reporting Form, laboratory-confirmed influenza cases are reported. Therefore, lab-confirmed influenza outbreaks may be detected via this Cumulative ARI Reporting Form. In the instance of a lab-confirmed influenza outbreak meeting a to-be-determined threshold, this Influenza Outbreak Enhanced Data Collection Form (formerly known as Influenza-like-Illness Outbreak Enhanced Data Collection Form) may be sent to the ship.
Impact on Small Businesses or Other Small Entities
This data collection will not involve small businesses.
The proposed information collection request does not impact small businesses or other small entities. Respondents are primarily state local, territorial health department officials, and cruise ship medical staff or cargo ship managers.
Consequences of Collecting the Information Less Frequently
The frequency of the proposed data collection is determined by the incidence of travelers who develop an illness or die from a communicable disease of public health concern. Information will only be collected if these incidences occur during travel by air, sea, or rarely land-based conveyance and are reported to a CDC Port Health Station at a port of entry. Control of communicable diseases of public health concern is dependent on rapid identification and immediate response when identified. Information will only be collected when it is essential to protect the public’s health. Further reduction of required reporting would prevent CDC from meeting its legislative mandate, thereby endangering the public’s health.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
This request fully complies with the regulation 5 CFR 1320.5.
A. A 60-day Federal Register Notice was published in the Federal Register on June 4, 2024, vol. 89, No. 108, pp. 47957-47958 (Attachment B). CDC did not receive comments related to this notice.
B. CDC conducted focus groups with representatives from 9 health departments about potential modifications to the TB Aircraft Contact Investigation Outcome Reporting Form. These representatives agreed with potential changes identified by DGMH staff and proposed several additional modifications to the wording and/or order of the questions that are addressed in the final version of the form submitted with this package and documented in Section 15.
No monetary incentives or gifts are provided to respondents.
Protection of the Privacy and Confidentiality of Information Provided by Respondents
This information collection request has been reviewed by the National Center for Emerging and Zoonotic Infectious Diseases and determined that the Privacy Act applies 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 (Attachment C).
Data will be kept private to the extent allowed by law.
Institutional Review Board (IRB) and Justification for Sensitive Questions
Institutional Review Board (IRB)
NCEZID’s Human Subjects Advisor has determined that information collection is not research involving human subjects (Attachment D). IRB approval is not required.
Justification for Sensitive Questions
These forms collect three types of data: 1) Epidemiologic data such as travel itinerary, exposure to ill people or animals, history of illness or vaccination, and country of birth/residence are essential to accurately determine an individual traveler’s public health risk; 2) Demographic data such as age and gender are routinely collected as part of standard public health surveillance. Under OMB Control Number 0920-1181 Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form CDC receives from airlines the name and date of birth of travelers who were potentially exposed to a communicable disease of public health concern during air travel. CDC sends the name and date of birth of these air traveler contacts to the state or territorial health department for public health follow-up. The air travel related contact investigation outcome reporting forms included in this ICR package collects this information (name and date of birth) in order to connect the additional information reported to the correct individual.; and 3) Clinical information such as clinical signs and symptoms and sign/symptom development, medical evaluation, lab testing, etc. All of these data elements are essential to efficiently detect a public health threat and rapidly implement appropriate public health control measures to prevent the introduction and spread of communicable diseases in the U.S.
A. Estimated Annualized Burden Hours
The number of times these data are collected remains dependent upon the number of exposure events of public health concern that occur within each data collection period. For the standard contact investigation forms, the number of times these data are collected remains dependent upon the number of exposure events of public health concern that occur within each data collection period, and the number of times the state, local, or territorial public health agency or airline, maritime, or land-based conveyance operator decides to respond to CDC with the follow-up information.
Additionally, because contact investigations involving ships almost always occur on the ship prior to making port, only one form is needed per investigation. In an aircraft contact investigation, one form is requested per contact given how dispersed travelers are after termination of travel.
CDC estimated the number of respondents by reviewing respondent data in 2021-2023, excluding COVID-19. These estimates result in a total of 30 burden hours for this information collection.
CDC is requesting approval for the use of the following forms and associated burden:
TB Maritime Contact Investigation Worksheet (Attachment E): 17 respondents and 10 minutes per response, for a total of 3 burden hours.
Varicella Outbreak Enhanced Data Collection Form – Maritime (Attachment F): 74 respondents and 10 minutes per response, for a total of 12 burden hours
Influenza Outbreak Enhanced Data Collection Form - Maritime (Attachment G): 10 respondents and 10 minutes per response, for a total of 2 burden hours
General Aircraft Contact Investigation Outcome Reporting Form (Attachment H): 8 respondents and 5 minutes per response, for a total of 1 burden hours.
TB Aircraft Contact Investigation Outcome Reporting Form (Attachment I): 51 respondents and 10 minutes per response, for a total of 9 burden hours.
Measles Aircraft Contact Investigation Outcome Reporting Form (Attachment J): 72 respondents and 5 minutes per response, for a total of 6 burden hours.
Rubella Aircraft Contact Investigation Outcome Reporting Form (Attachment K): 1 respondents and 5 minutes per response, for a total of 0 burden hours.
General Land Contact Investigation Outcome Reporting Form (Attachment L): 2 respondents and 5 minutes per response, for a total of 0 burden hours.
Type of Respondent |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Average Burden per Response |
Total Burden Hours |
Cruise Ship Physicians/Cargo Ship Managers |
TB Maritime Contact Investigation Worksheet (Attachment E) |
17 |
1 |
10/60 |
3 |
Cruise Ship Physicians |
Varicella Outbreak Enhanced Data Collection Form - Maritime
(Attachment F) |
74 |
1 |
10/60 |
12 |
Cruise Ship Physicians |
Influenza Outbreak Enhanced Data Collection Form - Maritime
(Attachment G) |
10 |
1 |
10/60 |
2
|
State/Local/Territorial public health staff |
General Contact Investigation Outcome Reporting Form -Air
(Attachment H) |
8 |
1 |
5/60 |
1 |
State/Local/Territorial public health staff |
TB Aircraft Contact Investigation Outcome Reporting Form
(Attachment I) |
51 |
1 |
10/60 |
9 |
State/Local/Territorial public health staff |
Measles Contact Investigation Outcome Reporting Form – Air
(Attachment J) |
72 |
1 |
5/60 |
6 |
State/Local/Territorial public health staff |
Rubella Contact Investigation Outcome Reporting Form - Air
(Attachment K) |
1 |
1 |
5/60 |
0 |
State/Local/Territorial public health staff |
General Land Contact Investigation Outcome Reporting Form
(Attachment L) |
2 |
1 |
5/60 |
0 |
Total |
|
33 |
|||
B. Estimated Annualized Burden Costs
Respondents for this information collection include Cruise Ship Physicians or Cargo Ship Managers (for the maritime travel-related contact investigation reporting forms) and state/local/territorial public health staff. To estimate the annualized burden cost for contact investigation reporting forms completed by cruise ships, we have used the middle of the salary range reported for cruise ship physicians ($8,000-14,000 per month, according to Crew Center).
To estimate the annualized burden cost for the contact investigation reporting forms completed by state, local, or territorial health departments, we have taken the median income of Epidemiologists, which is $43.48 per hour (according to the U.S. Bureau of Labor Statistics, May 2023: http://www.bls.gov/oes/current/oes191041.htm).
Payment can vary widely depending on training level, physician vs nurse, or other mid-level staff. We feel reporting the Epidemiologist costs from US-trained epidemiologists is a reasonable approximation. Doing so results in an estimated annualized burden cost of approximately $1,820.
Type of Respondent |
Form Name |
Total Burden Hours |
Wage Rate |
Costs |
Cruise Ship Medical Staff/Cargo Ship Managers |
TB Maritime Contact Investigation Worksheet
(Attachment E) |
3 |
$72 |
$216 |
Cruise Ship Medical Staff/Cargo Ship Managers
|
Varicella Outbreak Enhanced Data Collection Form – Maritime
(Attachment F) |
12 |
$72 |
$864 |
Cruise Ship Medical Staff/Cargo Ship Managers
|
Influenza Outbreak Enhanced Data Collection Form – Maritime
(Attachment G) |
2 |
$72 |
$144 |
State/Local/Territorial public health staff |
General Contact Investigation Outcome Reporting Form -Air
(Attachment H) |
1 |
$43.48 |
$43.48 |
State/Local/Territorial public health staff |
TB Aircraft Contact Investigation Outcome Reporting Form
(Attachment I) |
9 |
$43.48 |
$391.32 |
State/Local/Territorial public health staff |
Measles Contact Investigation Outcome Reporting Form – Air
(Attachment J) |
6 |
$43.48 |
$260.88 |
State/Local/Territorial public health staff |
Rubella Contact Investigation Outcome Reporting Form - Air
(Attachment K) |
0 |
$43.48 |
$0 |
State/Local/Territorial public health staff |
General Land Contact Investigation Outcome Reporting Form
(Attachment L) |
0 |
$43.48 |
0 |
Total |
|
$1,919.68 |
||
Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
There is no total annual cost burden to respondents or record keepers other than their time.
Annualized Cost to the Government
As defined by CDC’s regulatory authority and responsibility, routine contact investigations are ongoing. For routine costs, CDC estimates that it requires the equivalent of approximately 2 hours of CDC staff (GS-12 base, Atlanta locality) time to distribute and collect the contact investigation outcome reporting forms, along with some basic transcription of the data into PHARS. Total costs for these activities within the routine contact investigations are as follows:
Expense Type |
Pay Scale |
# of Contact Investigations |
Time/Contact |
Total Cost |
Staffing-Public Health Advisor |
GS12 base, ATL Locality ($44.03) |
92 |
Two Hours |
$4,050.76 |
PHARS Routine Maintenance and Development |
|
|
|
$200,000.00 |
Total |
$204,050.76 |
|||
There are also system and personnel costs associated with the use, development, and maintenance of PHARS. These costs include the IT costs and associated staffing costs. The PHARS-related costs dedicated only to the contact investigation process cannot be separated from the total PHARS system costs; therefore, the total PHARS costs are included. Staffing costs for the routine maintenance and development of PHARS are also included. Annual costs for routine maintenance and development of PHARS are approximately $200,000.
The total annual cost for routine contact investigations included in this information collection is $204,050.76.
Explanation for Program Changes or Adjustments
CDC has updated the burden to account for changes after the COVID-19 pandemic. The burden for this information collection request has decreased from 1,422 to 33 hours, primarily due to a decrease in contact investigations for COVID-19.
Additionally, the following changes are requested to the forms under this control number:
TB Maritime Contact Investigation Worksheet (Attachment E)
Burden: Updated burden hours to reflect a minor increase in maritime TB contact investigations and updated wage rate to reflect the fact that these forms are typically completed by ship physicians, not epidemiologists. This resulted in a decrease in cost from $402 to $216.
Name change from “Clinically Active TB Contact Investigation Outcome Reporting Form – Maritime” to “TB Maritime Contact Investigation Worksheet.”
Varicella Outbreak Enhanced Data Collection Form – Maritime (Attachment F)
Burden: Updated burden hours to reflect an increase in varicella maritime contact investigations and updated wage rate to reflect the fact that these forms are typically completed by ship physicians, not epidemiologists. This resulted in an increase in cost from $536 to $864.
Name change to Varicella Outbreak Enhanced Data Collection Form - Maritime
Top of the form,
Add indications for form and instructions to limit questions received from the cruise ship physician/cargo ship manager: “At least 3 varicella cases on this ship have been reported to CDC Port Health Stations, with each case occurring within 42 days of one another. For this varicella outbreak, please enter information applicable to all cases below.”
Question: “Case: Were all persons with suspected varicella medically evaluated?”
Remove question to limit redundancy with reporting requirements.
Question: “Treatment: How many persons with suspected varicella were treated with antiviral (acyclovir) treatment?”
Remove redundant language in data field.
Section “Prophylaxis”
Remove “asymptomatic” from both questions as this was unnecessary.
Remove redundant language in data field for each question.
Section: “Morbidity & Mortality”
Remove question on hospitalized persons as this information is collected in the required Maritime Conveyance Illness or Death Investigation Form (OMB Control Number 0920-0134
Remove question on fatalities due to suspected varicella as maritime vessels are required to report all fatalities under federal regulations (42 CFR 71.21).
Footnotes:
Information on the infectious period has been revised based on recommendations from CDC subject matter experts.
Additional wordsmithing and formatting changes were made.
Influenza Outbreak Enhanced Data Collection Form – – Maritime (Attachment G)
Burden: Updated burden hours to reflect the fact that influenza outbreak investigations have decreased and updated wage rate to reflect the fact that these forms are typically completed by ship physicians, not epidemiologists. This resulted in a decrease in cost from $804 to $144.
Change name to “Influenza Outbreak Enhanced Data Collection Form – Maritime” to more appropriately reflect the form’s indicated use.
General Aircraft Contact Investigation Outcome Reporting Form (Attachment H)
Burden: Updated burden hours to reflect a decrease in general contact investigations associated with COVID-19. The previous submission multiplied the median income of epidemiologists by two to account for “non-wage benefits and other overhead”; this adjustment was removed for consistency with other submissions. These changes resulted in a decrease in cost from $11,702 to $43.
Header and Section 1 (“Flight Information”):
Title change from “Air” to “Aircraft.”
“DGMQ” changed to “DGMH” to reflect the recent change in the name of the Division.
Add fax number for health departments that are not able to send personally identifiable information by secure email.
Section 1: “Flight Information”
Remove “(If more than one flight is listed, please circle the flight contact was on)” as separate forms for each flight are sent to state and territorial health departments.
Section 2: “Index Case Clinical and Lab Information”
Add a data field identifying the infectious traveler’s diagnosis.
Section 7: “Public Health Intervention”
For answer choice “Yes” (i.e., indicating the exposed traveler received post-exposure prophylaxis) language was revised to clarify the respondent should indicate what type of prophylaxis was received.
Section 8: “Diagnosis”
Under last question about recent potential exposures, added an additional answer choice: “Visited/lives in a country with high burden of disease”
Add new section (“Form Completion”) as section 9
Add a field for the name of the person completing the form to facilitate follow-up.
Add data field for the date the form was completed to facilitate the analyses of reporting timeliness.
TB Aircraft Contact Investigation Outcome Reporting Form (Attachment I)
Burden: Updated burden hours to reflect an increase in TB aircraft contact investigations. The previous submission multiplied the median income of epidemiologists by two to account for “non-wage benefits and other overhead”; this adjustment was removed for consistency with other submissions. These changes resulted in an increase in cost from $254 to $391.
Header and Section 1 (“Flight Information”):
Title changed from “Air” to “Aircraft”
“DGMQ” changed to “DGMH” to reflect recent change in the name of the Division.
Add fax number for health departments that are not able to send personally identifiable information by secure email.
Section 1: “Flight Information”
Remove “If more than one flight is listed, please circle the flight contact was on” (not needed).
Section 3 – “Passenger Contact Information”
Add “Passport Country” per health department request (helps them to prepare for what language support services might be needed).
Change “lives in a different jurisdiction” to “lives in a different state/territory” to avoid this option being selected when the contact has moved to a different area within the same state.
Section 4 – “Contact Information”
Remove “Was this person a known close contact of the index case outside the flight?” (moving to Section 5 with other risk factors).
Change “Country of Residence” to “Country of Usual Residence” to harmonize with terminology used by the Division of Tuberculosis Elimination.
Section 5 – “Interview Information”
Add additional modifiers to the risk factors question to clarify that we’re interested in risk factors for exposure (“social risk factors”), not risk factors for progression (“medical risk factors”)
In “Risk factors for prior TB Infection” section, add checkbox for “Close contact of the index case outside the flight.”
Add a question asking whether a person previously diagnosed with TB/LTBI had received treatment.
Change footnote about what to do if uncertain if a country has high TB prevalence:
Previously instructed respondent to list the country for DGMH to make the determination.
Revised version: “please refer to the”
Section 6 – “TB Screening and Evaluation”
Replace “Was a review of signs and symptoms completed” with “Did the person have signs and symptoms of TB?” [Answer choices: Yes, No, Not evaluated] and move to the top of the section for more logical flow.
In the diagnosis section, change “Unknown” to “Undetermined”
In the question about treatment, change from “diagnosed with TB” to “diagnosed with TB disease or LTBI” to improve clarity.
Section 7 – “Form Completion”
Add a field for the name of the person completing the form to facilitate follow up.
Add a field for the date the form was completed to facilitate analyses of the timeliness of reporting.
PRA Statement
Time per response updated to 10 minutes based on discussions with health departments.
Updated address and PRA number.
Measles Aircraft Contact Investigation Outcome Reporting Form (Attachment J)
Burden: Updated burden hours to reflect an increase in TB aircraft contact investigations. The previous submission multiplied the median income of epidemiologists by two to account for “non-wage benefits and other overhead”; this adjustment was removed for consistency with other submissions. These changes resulted in a decrease in cost from $489 to $261.
Header and Section 1 (“Flight Information”):
Title change from “Air” to “Aircraft.”
“DGMQ” changed to “DGMH” to reflect the recent change in the name of the Division.
Add fax number for health departments that are not able to send personally identifiable information by secure email.
Section 1: “Flight Information”
Remove “(If more than one flight is listed, please circle the flight contact was on)” as separate forms for each flight are sent to state and territorial health departments.
Section 4: “Contact/Interview Information”
Add a question about timing of the interview (i.e., within the post-exposure prophylaxis period, after the completion of the incubation period, or during both time periods). This question aligns with a similar question included in the “General Aircraft Contact Investigation Outcome Reporting Form.”
Section 5: “Immunity”
Add “select one” as only one of the answer choices should apply
Add “Born before 1957” to “History of disease” answer choice as being born before 1957 is acceptable as presumptive evidence of immunity against measles.
Section 6: “Measles Intervention Related to Exposure on the Flight”
Add “select one” after “No” to limit misinterpretation of the reason why a contact did not receive post-exposure prophylaxis.
Move “History of measles prior to flight” from the “Immune” answer choice to a separate answer choice. This also aligns with section 5 and CDC’s acceptable presumptive evidence of immunity against measles.
Add “serology” to “Immune” answer choice (with “by vaccination”)
Section 8: “Diagnosis”
Move the last question to Section 7 (“Health Since Flight”): “Check any of the following potential measles exposures this person may have had in the 21 days prior to symptom onset.”
Add new section (“Form Completion”) as section 9
Add data field for the date the form was completed to facilitate the analyses of reporting timeliness.
Add a field for the name of the person completing the form to facilitate follow-up.
Rubella Aircraft Contact Investigation Outcome Reporting Form (Attachment K)
Burden: Burden hours were rounded in 2024 but not in the 2021. This change resulted in a decrease in cost from $34 to $0.
Header and Section 1 (“Flight Information”)
Title change from “Air” to “Aircraft.”
“DGMQ” changed to “DGMH” to reflect the recent change in the name of the Division.
Add fax number for health departments that are not able to send personally identifiable information by secure email.
Section 1: “Flight Information”
Remove “(If more than one flight is listed, please circle the flight contact was on)” as separate forms for each flight are sent to state and territorial health departments.
Section 4: “Contact/Interview Information”
Add a question about the timing of the interview (i.e., within the post-exposure prophylaxis period, after the completion of the incubation period, or during both time periods). This question aligns with a similar question included in the “General Aircraft Contact Investigation Outcome Reporting Form.”
Section 8: “Diagnosis”
Move the last question to Section 7 (“Health Since Flight”): “Check any of the following potential rubella exposures this person may have had in the 23 days prior to symptom onset.”
Add new section (“Form Completion”) as section 9
Add data field for the date the form was completed to facilitate the analyses of reporting timeliness.
Add a field for the name of the person completing the form to facilitate follow-up.
General Land Contact Investigation Outcome Reporting Form (Attachment L)
Burden: Updated burden hours to reflect a decrease in general contact investigations associated with land travel. The previous submission multiplied the median income of epidemiologists by two to account for “non-wage benefits and other overhead”; this adjustment was removed for consistency with other submissions. These changes resulted in a decrease in cost from $101 to $0.
Change name to: “General Land Contact Investigation Outcome Reporting Form”
Section 1: “Travel Information”
The proposed activities are routine and reoccurring data collections, the time schedules for which are determined by the frequency of exposure to a communicable disease resulting in a contact investigation. Both daily and incident-specific reports are generated for CDC staff using PHARS data. CDC Port Health Station staff plan to use the data, aggregated to protect the privacy of any individually identifiable information, to provide the public, partners, and other stakeholders information about contact investigation, and to evaluate and improve CDC’s investigative protocols. Data are not collected for statistical use. There are no current plans to publish any information collected in this request.
Reason(s) Display of OMB Expiration Date is Inappropriate
The display of the OMB Expiration date is not inappropriate.
There are no exceptions to the certification.
Attachments
Attachment A1: Section 361 of the Public Health Service (PHS) Act (42 USC 264)
Attachment A2: 42 CFR part 70
Attachment A3: 42 CFR part 71
Attachment B: 60 Day Federal Register Notice
Attachment C: System of Records Notice (09-20-0171)
Attachment D: Non-research Determination
Attachment E: TB Maritime Contact Investigation Worksheet
Attachment F: Varicella Outbreak Enhanced Data Collection Form - Maritime
Attachment G: Influenza Outbreak Enhanced Data Collection Form - Maritime
Attachment H: General Aircraft Contact Investigation Outcome Reporting Form
Attachment I: TB Aircraft Contact Investigation Outcome Reporting Form
Attachment J: Measles Aircraft Contact Investigation Outcome Reporting Form
Attachment K: Rubella Aircraft Contact Investigation Outcome Reporting Form
Attachment L: General Land Contact Investigation Outcome Reporting Form
Attachment M: PHARS Privacy Impact Assessment
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Samuel, Lee (CDC/OID/NCEZID) |
| File Modified | 0000-00-00 |
| File Created | 2024-09-05 |
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