Justification for Non-Substantive Change Request

Change Request 0920-0004_FINAL_clean3.docx

National Disease Surveillance Program - II. Disease Summaries

Justification for Non-Substantive Change Request

OMB: 0920-0004

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0920-0004 National Disease Surveillance Program II-Disease Summaries

(Expiration 10/31/2017)

Non-Substantive Change Request






























Program Official/Project Officer

Lee Samuel

OMB Specialist

Office of the Director

National Center for Emerging and Zoonotic Infectious Diseases

1600 Clifton Road, NE, MS C12

Atlanta, Georgia 30333

Phone: 404-639-1045

Fax Number: 404-639-7090

Email: [email protected]

This is a nonmaterial/non-substantive change request for OMB Control No. 0920-0004, expiration date 10/31/2017. This ICR covers the reporting of foodborne, enteric person-to-person, animal contact, environmental contamination other than food/water, other/unknown modes of transmission, and waterborne outbreak data from 59 sites (50 US states, the District of Columbia, five US territories, and three Freely Associated States) to the National Outbreak Reporting System (NORS).

CDC requests OMB approval for non-substantive changes to two forms included in ICR No. 0920-0004:

  • Form 52.13, Foodborne Disease Transmission_Person to Person_Animal Contact (Attachment A)

  • Form 52.12, Waterborne Diseases Outbreak Form (Attachment B)

The requested changes would increase the total number of estimated annualized burden hours for this information collection by 91 hours. The requested changes would increase the estimated cost burden by $8,251. However, this increase is due primarily to updated wage estimates, not a substantial increase to the burden.

CDC Form 52.13, Foodborne Disease Transmission_Person to Person_Animal Contact (Attachment A)

Description/Justification of changes: Data elements requiring change will improve clarification and readability of the data collection form; see table below. Most changes to the form are label changes that will improve clarity and accuracy of the question asked. These label changes should not impact the burden on reporters except through improved readability.

  • We request the addition of questions on antimicrobial susceptibility testing. Reporters should have this information readily available from the investigation and it would not increase the burden to report. These questions are important for linking to the National Antimicrobial Resistance Monitoring System and provide data on antimicrobial resistance in outbreaks. Monitoring antimicrobial resistance has become a priority for CDC and the nation. Collecting these data will aid in efforts to monitor this emerging problem.

  • We request to add questions to clarify if a food vehicle was identified or suspected and if there was a kitchen manager certified in food safety located at the location of preparation. These additional questions would not add burden to the reporter as they would be answered in the outbreak investigation.

  • In addition, we would remove the Additional Salmonella Questions.

  • We request the addition of nine questions to the animal contact section. These questions would be answered by the outbreak investigation and should not add burden on reporting. Although these are nine additional questions, the time burden is estimated based on the longest possible form entry, which is foodborne. The animal contact section is much shorter than the foodborne section, allowing the time burden to fall within the estimated 20 minutes.

  • We request the addition of questions to gain further data on Shigella outbreaks. These three questions will only be asked if the etiology of the outbreak is Shigella and the mode of transmission is person-to-person or unknown. These additional questions will not affect the burden of reporting because they will not be completed for foodborne outbreaks.

The data collection changes are summarized in the table below.

Proposed Form Changes: CDC 52.13

Section

Current Question/Item

Requested Change

General

Signs or Symptoms, ‘Feature’

Change ‘Feature’ to ‘Sign or Symptom’

General

Asymptomatic as a sign or symptom

Remove this as a printed option.

General

Environmental Health Specialists Network

Change to ‘Other System IDs’

General

EHS-Net Evaluation ID

Change to ‘NEARS ID’

General


Add under ‘Other System IDs,’ OHHABS ID

General

Reporting State

Change to Reporting site

Etiology


Add ‘Clinical and Environmental Testing’ subheading

Etiology

Were any specimens collected and tested?

Change specimens to samples

Etiology

How many specimens of each type were tested?

Change specimens to samples

Etiology


Add: Was antimicrobial susceptibility testing (AST) performed? [Yes, no, unknown]

Etiology


Add: If yes, where was AST performed? [clinical lab, PHL, CDC-NARMS, other, unknown]

Etiology


If yes, were any antimicrobial resistant isolates associated with the outbreak? [Yes, no, unknown]

Etiology


Add: CDC System to Isolates/Strains table

Etiology

State lab ID/Accession ID/CaliciNet key

State lab ID/Accession ID/CaliciNet key/PulseNet key

Etiology

CaliciNet sequenced region/other molecular designation 1

CaliciNet sequenced region/whole genome sequencing ID

Etiology

CaliciNet sequenced region/other molecular designation 2

CaliciNet sequenced region/other molecular designation

Settings

Major and other setting of Exposure picklist values.

Add: unknown, Shelter/group home/transitional housing as options.

Settings


Add: Specify setting [free text] field

Settings


Add: Further Shigella Questions subheading

Settings


Add: 1. Did any case-patients report travel prior to illness onset? [Yes, No; Unsure/unknown]

If yes, was travel international, domestic, or both? [International, Domestic, Both, Unknown]

2. Were any confirmed, suspected, or probable case-patients immunocompromised (e.g., HIV/AIDS)? [Yes, No, Unsure/Unknown]

3. Were there any confirmed, suspected, or probable cases among men who have sex with men? [Yes, No, Unsure/Unknown]

Animal Contact


Add: Animal vehicle undetermined [checkbox];

Reason(s) animal contact, but undetermined vehicle

Animal Contact


Add: Animal type (specify)

Animal Contact


Add: Confirmed or suspected vehicle

Animal Contact


Add: Reason(s) confirmed or suspected

Animal Contact


Add: Did any cases have exposure to livestock or household pets that were experiencing diarrhea? [Yes, No, Unknown]

Animal Contact


Add: Was pet food or animal feed implicated as a potential source of the outbreak? [Yes, no, unknown]


If yes, please specify:

Prepackaged pet food

Pet treats or chews

Homemade pet food

Commercially prepared 'raw' pet food

Frozen or fresh feeder rodents

Blended feed

Other (specify)

Unknown

Animal Contact

Setting of Exposure

Setting of Exposure (check all that apply):

[Removed from table format]

Agricultural feed store

Animal shelter or sanctuary

Camp

Child day care

Farm/dairy

Festival or fair

Hospital

Laboratory

Live animal market

Long-term care/nursing home/assisted living facility

Pet store or other retail location

Petting zoo

Prison/jail

Private home/residence

School/college/university

Veterinary clinic

Zoo or animal exhibit

Other (specify)

Unknown

Animal Contact


Add: What prevention measures or recommendations were used to stop the outbreak and prevent additional infections (check all that apply)?

Handwashing

Quarantine/stop movement

Venue or event closure

Removal of animals from setting

None

Other (specify)

Unknown

Animal Contact


Add: Was the Compendium of Measures to Prevent Disease Associated with Animals in Public Settings used in the investigation? [Yes, no, unknown]

Food


Add: Reasons foodborne, but undetermined vehicle

Food


Add to food grid: Confirmed or suspected vehicle

Food


Was there a kitchen manager certified in food safety at the location of preparation? [yes, no, unknown]

Food

Confirmed or suspected point of contamination

Add: unknown option

Food

Was food worker implicated as the source of contamination

Add: unknown option

Food

*If multiple schools are involved, please answer according to the most affected school.

Edit:*If multiple schools are involved, please answer for the school with the most cases.

Food

Additional Salmonella Questions

Remove entire section

Burden

The estimated number of annualized burden hours is expected to increase by 90 hours, from 576 hours to 666 hours.

The change to the annualized burden hours is minimal because the reporting agencies currently collect these data elements for foodborne, person-to-person, and animal contact outbreaks. Therefore, the effort to include these additional data elements does not require up-front cost in hours. In addition, the changes to the annual submissions to CDC are not expected to change after these changes are implemented. There is an increase from 32 responses per respondent to 37 in 2016. This increase is based on median number of reports submitted by each state and territory in 2015; the number of reported outbreaks often fluctuates each year.

The burden hours were estimated based on the average time to complete the common data collection fields by multiple team members.

In the 0920-0004 revision approved in October, 2014, $23.20 was used for the mean hourly wage of state workers. In this change request, we are using the most recent data which indicates that the mean hourly wage of state epidemiologists is $32.15 (source: http://www.bls.gov/oes/current/oes191041.htm#ind).

In the approved ICR, the estimated burden for the completion of Form 52.13 was $13,363.20. The estimated burden now is $21,411.90, an increase of $8,048.80. The increase in cost is not likely to have been incurred over this short time span, rather the updated cost is a more accurate representation of the true burden than previously estimated.

Estimates of Annualized Burden Hours (requested changes are highlighted)

Respondents

Form name

Number of Respondents

Number of Responses per Respondent

Average Burden Per Response (in hours)

Approved burden (in hours)

Requested Burden (in hours)

Epidemiologist

CDC Form 52.13

54

37 (+5)

20/60

576

666 (+90)





Estimates of Annualized Cost Burden (requested changes are highlighted)

Respondents

Total Burden Hours

Hourly Wage Rate

Approved cost to respondents

Requested Respondent Cost

Epidemiologist

666 (+90)

$32.15 (+$8.95)

$13,363.20

$21,411.90 (+8,048.80)



CDC Form 52.12, Waterborne Diseases Outbreak Form (Attachment B)

The Waterborne Disease and Outbreak Surveillance System (WBDOSS) is a collaboration between the Centers for Disease Control (CDC), the Council of State and Territorial Epidemiologists (CSTE), and the Environmental Protection Agency (EPA). This system tracks and analyzes waterborne disease outbreaks in the United States. WBDOSS has received disease outbreak reports through the electronic National Outbreak Reporting System (NORS) since a revised form was approved by the Office of Management and Budget (OMB) in 2009. NORS variables correspond to variables in the CDC 52.12 form.

Description/Justification of changes: CDC requests revising Form 52.12 to include a new question to link to the One Health Harmful Algal Bloom System (OHHABS; OMB No. 0920-1105) and questions on antimicrobial susceptibility testing. Reporters would have this information available so it would not be expected to increase the burden to report. These questions are important for linking to the OHHABS and the National Antimicrobial Resistance Monitoring System, as well as providing data on antimicrobial resistance in outbreaks. Monitoring antimicrobial resistance has become a priority for CDC and the nation. Collecting these data will aid in efforts to monitor this emerging problem.

A complete list of changes to the form are detailed in the table below. Neither the actual annual number of reports nor the burden hours for users are expected to increase or decrease as a result of the changes present in the CDC 52.12, however updates have been made in the burden table to better reflect the maximum number of burden hours and cost burden independent of these changes. These updates are also described below.

Proposed Form Changes: CDC 52.12

Section

Current Question/Item

Requested Change

General

Signs or Symptoms, ‘Feature’

Change ‘Feature’ to ‘Sign or Symptom’

General

Asymptomatic as a sign or symptom

Remove this as a printed option and delete the blank data entry row

General

Environmental Health Specialists Network

Change to ‘Other System IDs’

General

EHS-Net Evaluation ID

Change to ‘NEARS ID’

General


Add under ‘Other System IDs,’ OHHABS ID

General

Reporting State

Change to Reporting site

Water-General

Other, specify:

Delete the text field after “Other” and redirect respondents to enter other values in an existing remarks field

Water-Etiology & Lab

Test types

Change to “Testing Information”

Water-Etiology & Lab

Test Types

Add label to existing question "1. Test types (Select all test types used for clinical specimens)

Water-Etiology & Lab


Add question 2: "2. Was Antimicrobial Susceptibility Testing (AST) performed? With answer choices of "Yes, No, Unknown".

Add sub-question: "If yes, where was AST performed?" with answer choices of "Clinical Lab, PHL, CDC-NARMS, Other, Unknown".

Add another sub-question "If yes, were any antimicrobial resistant isolates associated with the outbreak?" with answer choices of "Yes, No, Unknown"

Other or Unknown Water

Contributing factors

Add three contributing factor options to the list on the form:

-Ornamental fountain – presence of submerged lighting

-Ornamental fountain – lack of a written cleaning and maintenance program

-Ornamental fountain – presence of dirt, organic matter, or other debris in the water basin

Specimen type


Delete a data entry row

Burden

The estimated number of annualized burden hours for this form is expected to increase by one hour. The change to the annualized burden hours and cost is minimal because the reporting agencies currently collect these data elements for waterborne disease outbreaks.

NORS supports outbreak reporting by 59 sites (50 US states, the District of Columbia, five US territories, and three Freely Associated States). Therefore, the number of estimated respondents has been updated from 57 to 59. Not all 59 report each year so this update presents a maximum rather than an actual annual number of respondents. The one hour increase in annualized burden (from 19 hours to 20 hours) is due to the additional two respondents.

In addition, the burden cost was based on the form being completed by an epidemiologist at the reporting site. In the most recent revision of 0920-0004, $23.20 was used for the mean hourly wage of state workers. In this change request, we’re using the most recent data which indicates that the mean hourly wage of state epidemiologists is $32.15 (source: http://www.bls.gov/oes/current/oes191041.htm#ind). In the approved ICR, the total estimated burden was $440.80. The estimated burden now is $643.00, an increase of $202.20. The slight increase in cost is not likely to have been incurred over this short time span, rather the updated cost is a more accurate representation of the true burden than previously estimated.

Estimates of Annualized Burden Hours (requested changes are highlighted)

Respondents

Form name

Number of Respondents

Number of Responses per Respondent

Average Burden Per Response (in hours)

Approved burden (in hours)

Requested Burden (in hours)

Epidemiologist

CDC Form 52.12

59 (+2)

1

20/60

19

20 (+1)





Estimates of Annualized Cost Burden (requested changes are highlighted).

Respondents

Total Burden Hours

Hourly Wage Rate

Approved cost to respondents

Requested Respondent Cost

Epidemiologist

20 (+1)

$32.15 (+$8.95)

$440.80

$643.00 (+$202.20)



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