1024-NEW SSA_Epi. 10.5.2022

SUPPORTING STATEMENT A

FOR PAPERWORK REDUCTION ACT STATEMENT SUBMISSION

National Park Service (NPS) Office of Public Health (OPH)

NPS Case and Outbreak Investigation Data Collections

OMB Control Number 1024-New

Terms of Clearance: None

Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.

The National Park Service (NPS) and the Office of Public Health (OPH) is called upon by NPS leadership to conduct disease surveillance, respond to urgent outbreaks or events, and prevent disease transmission and illnesses within or associated with National Parks. The National Parks are federal lands, therefore, other state and local health departments do not have jurisdiction and the public health response rests with the NPS OPH. Currently, NPS OPH does not have a formal system in place to collect disease or event-related information. Past outbreaks including norovirus, hantavirus, plague, and mass bat exposures have demonstrated the need for formal epidemiological information collection.

NPS OPH is authorized by National Park Service and Related Programs (54 USC 100702) and the Public Health Service Act (42 USC 301) to regulate the use and promote the coordination of research in the park areas under its jurisdiction. NPS Reference Manual 83A require park managers to report the following events to the regional or park public health consultant, the OPH Epidemiology Branch Chief, or the One Health Coordinators:

• -three or more people connected to the National Park have similar symptoms

• -there is a single report of a rare disease or event

• -illness could result in death, serious injury, serious illness, or hospitalization

• -there is a wildlife encounter of concern (bite, scratch, attack)

• -there is any other illness of public health concern.

The NPS OPH is requesting approval to gather information from the public, employees, and other partners as needed to assist with environmental issues, conduct disease surveillance, respond to outbreaks and provide other services to protect public health. The ability of the NPS OPH to conduct epidemiological investigations is vital to protecting the health of the public. During an unanticipated outbreak or event, immediate action by NPS OPH is necessary to minimize or prevent harm to those within or associated with the National Parks.

Legal Authorities and Policies

• National Park Service and Related Programs (54 USC 100702)

• Public Health Service Act (42 USC 301)

• NPS Management Policy 2006, 8.2.5.5 –

• NPS Reference Manual 83A -

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection. Be specific. If this collection is a form or a questionnaire, every question needs to be justified.

This request is to use a form and telephone interviews to collect information related to general outbreak occurrences within NPS management areas. During an outbreak/event, we will collect information to determine the level, intensity, and nature of the outbreak. Table 1 describes the type and use of the questions in this information collection. The information collected will primarily be used by the NPS OPH to identify the: (1) causative agent, (2) sources of exposure (3) modes of transmission and (4) risk factors.

This information will be used to guide response efforts and control measures. NPS OPH will share information with local, state, territorial, and federal public health agencies as necessary to meet reporting requirements and enable collaboration during public health events. Collaboration is essential since the NPS visitor, employee, and partner populations are part of the community. Increases in cases of outbreaks can occur rapidly and the ability to collect timely information will lead to rapid responses needed for directed public health actions.

Table 2. 1. Generic outbreak questionnaire information to be collected and purpose/use

Section	Information Collected	To determine…	Purpose and Use
1	Demographic/Contact Information	who is infected	This information will be used to look for trends during an outbreak and characterize the population at risk. This information will allow NPS OPH to communicate with other public health agencies about cases within their jurisdiction.
2	Travel and National Park Visitation	how the occurrence entered the park unit	Information about transportation mode and tours will be used to inform parks and public health agencies within proximity to identify areas that may have the potential to be exposed.
3	Clinical Information	Type of illness, infectiousness	The responses to this question will be used to establish a case definition, track onset, duration of illness, and other clinical outcomes, needed to inform appropriate public health interventions to prevent spread of illness to employees and visitors
4	Medical Care and Notifications	communication strategies	This information will be used to ensure proper medical follow-up and care is provided.
5	Additional Information		As needed to guide public health response.
6	Exposure Information	type of infection	This information will be used to evaluate a case for zoonotic or infectious disease risk, direct follow-up actions, and initiate mitigation strategies.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden and specifically how this collection meets GPEA requirements.

The NPS OPH will use Microsoft Forms to collect information electronically 95% of the time and paper forms to collect information 5% of the time from affected populations. Microsoft Forms will be fillable.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

There is no duplication. No other Federal agency or NPS program funds or collects this type of information in parks.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

There is no additional burden to small businesses.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

NPS OPH has an obligation (as detailed in the MOA and MOU described above) to identify and share information with relevant public health agencies for reportable diseases. With more than 300 million visitors, 20,000 employees, 25,000 concessions employees, and many others that are connected to the National Parks, there is a large population at risk for a disease or public health event at any given time. Failure to collect epidemiological information will impede our ability to respond to disease outbreaks or events of public health concern and will leave parks and visitors at risk. The timeliness of collecting case information is one of the most critical factors in the rapid response process and allows NPS to alert those at risk for disease transmission with accurate and timely information.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

* requiring respondents to report information to the agency more often than quarterly;

* requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

* requiring respondents to submit more than an original and two copies of any document;

* requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

* in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study;

* requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

* that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

* requiring respondents to submit proprietary trade secrets, or other confidential information, unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and in response to the PRA statement associated with the collection over the past three years, and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every three years — even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

On January 27, 2022, we published in the Federal Register notice (87 FR 4283) of our intent to request that OMB approve this information collection. In that Notice, we solicited comments for 60 days, ending on March 28, 2022. We received no comments during the comment period.

In addition to the Federal Register Notice, nine individuals familiar with the program were asked to review the form and to provide feedback. The following table includes the titles and organizations of the individuals providing feedback to our request.

Position	Affiliation
Communications	CDC DVBD
Epidemiologist/Veterinarian	CDC
PHAP	CDC
State Public Health Vet	Utah Department of Health
Public Health	Utah Department of Health
Public Health	Utah Department of Health
Public Health	Utah Department of Health
EIS Officer	CDC DVBD
Public Health Intern	NPS

 

“Whether or not the collection of information is necessary, including whether or not the information will have practical utility; whether there are any questions they felt were unnecessary.” 

Respondent
#1	This collection of information is necessary to understand and investigate possible infectious disease outbreaks on National Park lands. The questions are useful; none are unnecessary.
#2	The collection of this information is necessary to prevent and respond to disease outbreaks on Federal land within the National Parks that may be outside of the jurisdiction of state/local health departments. The requested information is practical and relevant to the exposures that may occur within National Parks. No questions seem unnecessary, and all seem valuable to the investigation tool.
#3	All of the questions follow from the established steps of an outbreak investigation and thus all should provide necessary information for detecting, responding to, and containing disease outbreaks. None of the questions seem superfluous.
NPS Response/Action Taken: None
#9	In the demographic/contact information section, the question that asks about age seems unnecessary since the question before asks for the DOB. I assume it is there to make the analyzer’s life easier, but it may seem a bit burdensome for the respondent. In the clinical information section, question #6 that asks about test results may not be comprehensive enough with its options for answering. Answers will be very dependent on the type of test.
NPS Response/Action Taken: We removed age and will only use DOB. We kept the test results question as is since it will be specific to an exposure/concern.

“What is your estimate of the amount of time it takes to complete each form in order to verify the accuracy of our estimate of the burden for this collection of information?” 

Respondent
#1	20 minutes
#2	I concur with the estimate that the form should take no more than 30 minutes per participant to complete.
#3	The form should take 10-15 minutes to complete at the upper end.
#4-7	30-45 minutes; faster once there is more experience with the form. Sometimes editing will be done to a form after several uses, and this may cause the form to be shorter or longer if arranged for better flow, or the need for additional questions for more thoroughness
#9	Approximately 20 minutes. Time can vary considerably for information that is not readily available to the respondent. The respondent then has to take time to gather such information before answering questions.
NPS Response/Action Taken: Based on these comments we have estimated the average respondent burden to be no more than 20 minutes.

 

“Do you have any suggestions for us on ways to enhance the quality, utility, and clarity of the information to be collected?” 

Respondent
#1	Suggest clarifying at the beginning of the tool whether the person completing the form is the sick person or a surrogate (parent, spouse, etc.) rather than waiting until question I.17. Recommend moving Section IV ahead of Section III. Otherwise, the questions are confusing and redundant. Maybe consolidate these sections? Specify “stream or lake” as possible unsafe sources of drinking water in foodborne questions 8 and 9. I don’t think the public knows how to identify bat guano or bat urine. Consider adding mosquito or flea exposure along with ticks, spiders, and scorpions.
NPS Response/Action Taken: Moved surrogate responder and relationship to patient question earlier. Moved medical care questions earlier and combined sections III and IV. Added (e.g., stream, lake) to food/water questions 8 and 9. Changed bat guano to bat feces but kept the intent of the question. Added flea and mosquito to rodent/vector question 3.
#2	For question 9, Would it be good to capture other close contacts that may not have stayed overnight and ask if any other close contacts are ill? (e.g., tour group members, day hiking partners, sexual partners, etc.). For questions 10 and 11, Clarify the two weeks prior to developing symptoms?
NPS Response/Action Taken: Added a multi-part question to ask about other close contacts. Clarified two-week travel history questions
#4-7	I have two suggestions, on the Clinical Info section, number 6, you should include a comment section or multiple ways someone can respond to test results. For example, if someone had a Chest x-ray, blood work and nasal swab done, you only have one spot to answer if these results were negative, positive, etc. I would recommend a comment section or a way to chart what each result was for each test. My second suggestion is under food/ water borne illnesses, number 7. You will ask an individual for a food history for the past four days, but I would recommend using a box like you already have times four (one for each day), or somehow to note the dates of the food history for ease of eligibility, cleanliness, and ease of information. In other words, a nice clean way to chart someone's food history for each day, instead of one spot for food history that is supposed to hold four days’ worth of info. Dates are important to add too. Suggestion to add a primary/preferred language question. Suggestion to add “monument” to Q. II.1 about parks visited. Suggestion to add the name of park/monuments to date collection Q II.2 Suggestion that only some of the items in the list below (Q.II.6) are activities. Consider rewording so that it encompasses activities and places visited. Suggestion to add the date of diagnosis in the medical section. Suggestion to add a checkbox to indicate ongoing illness. Suggestion to add “date of the collection” to the testing question. Suggestion to consider removing “obesity” as an immunosuppressing condition. Suggestion to add admission and discharge date to medical care section Suggestions to clarify animal exposure questions. Suggestion to add a bat exposure question
NPS Response/Action Taken: Updated the test results question to allow for multiple responses and added a chart to guide responses. Expanded the food history table to allow for 4 days of responses. Added “monument(s)” to question 1 in travel/visitation section. Added a spot for the name of the park in question II.2. Modified wording to include activities and places for question II.6. Added “date of diagnosis” to the clinical information section. Left duration of illness questions the same as respondents or interviewer can indicate if the illness is ongoing. Added “date of the collection”. Removed “obesity” from the immunosuppressed condition example list. Reworded animal contact/exposure questions as the reviewer suggested. Added a bat exposure contact question
#8	Suggestion to reword the race/ethnicity question. Suggestion to clarify if someone is answering as a surrogate how they should respond. Suggestion to clarify the time frame for if others who stayed with the case were sick. Suggestion to specify in the travel destination question (city, state, country). Suggestion to make diagnosis plural
NPS Response/Action Taken:  Adjusted the wording and order of the question and combined race/ethnicity into one question. Added a line to prompt the surrogate to answer questions on behalf of a case. Added, “within 7 days before/after spending time with the case”. Added clarity to previous travel questions (city, state, country). Revised “diagnosis” to “diagnosis (or multiple)”.

“Any ideas you might suggest which would minimize the burden of the collection of information on respondents?” 

Respondent
#1	Not sure if smoking (III.9. is relevant to the infectious disease investigation.)
NPS Response/Action Taken: Left smoking in as it can be an important factor in some diseases
#2	I recommend ensuring that participants can access the link to the form via both smartphones (SMS/text message) and email to increase ease of accessibility and likelihood of participation.
NPS Response/Action Taken: The form is accessible using a computer, tablet, or phone
#3	For more complicated cases, a phone call seems like it would minimize the burden of information collection as opposed to sending a discrete online form, as a phone call would allow OPH to tailor the questions in real time and prevent the need for repeated follow-ups.
NPS Response/Action Taken: Noted the suggestion and will consider calling participants in some cases rather than having them complete the form
#4-7	If you can get your hands on clinical notes from a doctor's office/ hospital, it will make retrieving info easier. Obviously also interviewing individuals sooner, the better information you will receive because it is easier to recollect. Knowing your interview questions will make an interview faster and less burdensome for people who want to get back to "life". Know the education you will be giving individuals too; everyone appreciates education about their illness such as how it was contracted, how to avoid it, etc.
NPS Response/Action Taken: Noted the suggestion and we will communicate with the appropriate contacts to obtain the information needed for appropriate public health follow-up.
#9	Suggestion: (1) update the test results question to allow for multiple responses (2) add a chart to guide responses. (3) Expand the food history table to allow for 4 days of responses. (4) Add “monument(s)” to question 1 in travel/visitation section. (5) Add a spot for the name of the park in question II.2. (6) Modify wording to include activities and places for question II.6. (7) Add “date of diagnosis” to the clinical information section. (8) Leave the duration of illness question the same as respondents or the interviewer can indicate if the illness is ongoing. (9) Add “date of the collection”. (10) Remove “obesity” from the immunosuppressed condition example list. (11) Reword animal contact/exposure questions as the reviewer suggested. (12) Add a bat exposure contact question.
NPS Response/Action Taken: Noted the suggestion and we have made the suggested updates.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

No payments or gifts are provided to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

Submitted forms are stored in compliance Central Files--Interior, NPS-10 - April 11, 1977, 48 FR 19075; modification published October 28, 2008, (73 FR 63992).  All hard copies of forms are kept in secure areas, locked file cabinets, and treated as confidential information. Only individuals with a need to use the information have access. The information collection complies with the Privacy Act of 1974 and OMB Circular A-130. Such information may be exempt from disclosure under the FOIA (5 U.S.C. 552).

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

In some situations, we may ask about clinical information and medical care which could be considered sensitive in nature. Clinical and medical information are needed to establish a case definition, identify additional cases, and ensure appropriate follow-up.

12. Provide estimates of the hour burden of the collection of information. The statement should:

* Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

* If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

* Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here.

This will be an on-going collection that will be used to conduct disease surveillance and respond to disease outbreaks/events. We anticipate receiving responses from at least 500 individual respondents. The average time, based on the outreach in Question 8 above, will be 20 minutes per response. The combined annual respondent burden for this collection is 167 hours. We estimate that the dollar value of the annual burden hours is $6,739. To estimate the annual hour burden, we used the Office of Personnel Management Salary Table 2022-DCB to determine the hourly rates and multiplied the hourly rate by 1.6 to account for benefits in accordance with News Release USDL-22-1892, June 22 Employer Costs for Employee Compensation— released September 20, 2022, for individuals to be $40.35 (including benefits), to calculate the total annual burden. Table 12.1 lists estimated respondent burden for this collection.

Table 12.1: Estimated Annual Respondent Burden and Cost

Reporting Form	Number of Responses	Estimated Burden per respondent (minutes))	Total Annual Burden (hours)	Hourly Wage and Salary (including benefits)	Total Annual cost of burden (rounded)
Respondents	500	20	167	$40.35	$6,739

13. Provide an estimate of the total annual non-hour cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected in item 12.)

* The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information (including filing fees paid for form processing). Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

* If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

* Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

We have not identified any non-hour cost burden costs.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information.

We estimate the total annual cost to the Federal Government for this collection to be $19,763 Table 3 below shows Federal staff, grade levels, and the tasks associated with this information collection.

We used the Office of Personnel Management Salary Table 2022-DCB to determine the hourly rates and multiplied the hourly rate by 1.6 to account for benefits in accordance with News Release USDL-22-1892, June 22 Employer Costs for Employee Compensation— released September 20, 2022, to estimate average hourly wages and to calculate benefits.

Table 14.1. Federal Employee Salaries and Benefits

Position	GS Level	Hourly Rate	Hourly Rate incl. benefits (1.6 x hourly rate)	Estimated time (hours)	Annual Cost
NPS Epidemiologist	14/5	$68.55	$109.68	104	$11,407
NPS Epidemiologist II	12/6	$50.22	$80.35	104	$8,356
Total					$19,763

15. Explain the reasons for any program changes or adjustments in hour or cost burden.

This is a new collection.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

There are currently no plans to publish any tabulated data from this collection. However, in some situations, a summary of an outbreak investigation may be published for the purposes of public health education. Outbreak investigation publications vary based on the nature of each outbreak, but generally, they describe the number and characteristics of the cases, an analysis of potential exposure sources, and a description of prevention/mitigation measures.

Outbreak investigations may be written up as a report. Reports will include only aggregate, de-identified information so that no one particular person can be identified.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

We will display the OMB control number and expiration date on the form and the opening page of the web-based form.

18. Explain each exception to the topics of the certification statement identified in "Certification for Paperwork Reduction Act Submissions."

There are no exceptions to the certification statement.

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