Part A

SUPPORTING STATEMENT FOR INFORMATION COLLECTION

UNITED STATES DEPARTMENT OF AGRICULTURE (USDA)

ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

VETERINARY SERVICES (VS)

CENTERS FOR EPIDEMIOLOGY AND ANIMAL HEALTH (CEAH),

NATIONAL ANIMAL HEALTH MONITORING SYSTEM (NAHMS)

NAHMS Emergency Burkholderia Epidemiologic Investigation

SUPPORTING STATEMENT FOR INFORMATION COLLECTION BY THE CENTERS FOR EPIDEMIOLOGY AND ANIMAL HEALTH (CEAH),

NATIONAL ANIMAL HEALTH MONITORING SYSTEM (NAHMS)¹

OMB NUMBER 0579-0376

NAHMS Emergency Epidemiologic Investigations

Generic IC

Burkholderia Pseudomallei Release

March 2015

1. Justification

1. Explain why the collection of this information is necessary

Collection and dissemination of animal health data and information is mandated by

7 U.S.C. § 391, the Animal Industry Act of 1884,² which established the precursor of APHIS, Veterinary Services, and the Bureau of Animal Industry. Legal requirements for examining and reporting on animal disease control methods were further mandated by 7 U.S.C. § 8308, 8314 of the Animal Health Protection Act, “Detection, Control, and Eradication of Diseases and Pests,” May 13, 2002³. This statute allows NAHMS to collect information through epidemiologic investigations.

APHIS would like to perform an emergency epidemiologic investigation under ICR 0579-0376 in response to the release of Burkholderia pseudomallei (Bpm) at the Tulane National Primate Research Center (TNPRC). Bpm is a Tier 1 select agent and as such the importance of understanding the extent to which it may have contaminated the environment or infected people, wildlife and livestock cannot be understated. The intent is to collect data on the potential exposure of domestic animals outside of the TNPRC from employees in contact with non-human primates at the TNPRC. Questions will include those associated with employee contact with their own domestic animals, any unusual clinical signs or mortality associated with their owned animals, contact with domestic animals that they do not own and similar information about clinical signs and mortality.

The circumstances listed below apply to this situation and are consistent with the terms of use of our emergency data collection authority:

• The outbreak is considered to be an emerging, zoonotic, or a foreign animal disease

• A delay in data collection would result in the loss of epidemiologic information essential to assist laboratory investigations and/or disease control efforts

2. Indicate how, by whom, and for what purpose the information is to be used. Indicate the actual use the Agency has made of the information received from the current collection.

The primary objective of NAHMS’ emergency epidemiologic investigations is to provide for the prevention and control of animal disease conditions and protect the U.S. livestock population from the introduction and spread of domestic, emerging, zoonotic, and foreign animal diseases. Bpm is not endemic in the United States and is regulated as a Tier 1 select agent. State and Federal animal health officials will use the information collected from TNPRC employees to understand the extent to which Bpm may have contaminated the environment or infected people, wildlife, and livestock. Data will also be used to interrupt disease transmission, and to develop control strategies (if necessary). Data may also be used to make recommendations to the public health community to support human health in the event of a zoonotic disease.

VS has been asked to conduct an investigation to:

• Identify the scope of the problem.

• Define and describe the affected population and the susceptible population.

• Predict or detect trends in disease occurrence and movement.

• Understand the risk factors for disease.

• Make recommendations for disease control.

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.

Paper questionnaires and phone interviews will be used to collect the information from respondents.

3. Describe efforts to identify duplication.

This situation is unique and the information needed is specific to the circumstances around the release. VS is working in collaboration with the Centers for Disease Control and the Environmental Protection Agency to ensure efforts are not duplicated.

3. If the collection of information impacts small business or other small entities, describe the methods used to minimize burden.

This questionnaire has been designed to collect the minimum amount of data required to respond to the emergency situation. Participation in this investigation is voluntary.

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

Without this type of activity VS’ ability to determine the spread of disease would be severely diminished. This investigation will help VS officials to determine the extent of disease spread, minimizing the public health risk for zoonotic diseases, and alleviate animal suffering.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner inconsistent with the general information collection guidelines in
   5 CFR 1320.5.

• 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 secret, 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.

No special circumstances exist that would require this collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

7. 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 form, and on the data elements to be recorded, disclosed, or reported. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency’s notice, soliciting comments on the information collection prior to submission to OMB.

During the previous study approval period, APHIS consulted with the following individuals concerning epidemiologic investigations:

Dr. Mike Strain

Louisiana Department of Agriculture and Forestry

5825 Florida Blvd

Baton Rouge, LA 70806

225-922-1233

Mike.strain@ldaf.state.la.us

Dr. Brent Robbins

Louisiana Department of Agriculture and Forestry

5825 Florida Blvd

Baton Rouge, LA 70806

985-264-4142

brobbins@ldaf.la.gov

Dr. Diane Stacy

Louisiana Department of Agriculture and Forestry

5825 Florida Blvd

Baton Rouge, LA 70806

225-202-1548

dstacy@ldaf.la.gov

Knowledgeable individuals from State and federal organizations have been consulted on this emergency investigation.

The Agency’s notice of information collection activity was announced in the Federal Register on Friday, May 2, 2014, pages 25093 - 25094. One comment was received from Jean Public expressing her disdain for any activity that the Agency engages in – this comment had no bearing on the information being collected.

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

No payments or gifts will be provided to respondents as a result of this activity.

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

NAHMS does not provide respondents with any assurance of confidentiality. Information on an individual operation may be disclosed if regulatory action is necessary. Whenever possible, NAHMS will attempt to ensure that any findings released publicly will be based on summary estimates. All completed survey forms will be stored securely in a limited-access records vault.

7. Provide additional justification for any questions of a sensitive nature.

No questions are of a sensitive nature are contained on the questionnaire.

7. Provide estimates of the hour burden of the collection of information.

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

A total of 15 burden hours are needed to complete this emergency epidemiologic investigation. A detailed burden estimate has been included on the enclosed APHIS 71 Form.

Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

Respondent costs: Estimated respondent costs for the information collection proposed are calculated based on a data collection estimate of $10.93 per hour. The total respondent cost for performing emergency epidemiologic assessments is $225 (15 hours * $15).

7. Provide an estimate of the total annual cost burden to respondents or record keepers resulting from the collection of information (do not include any hour burden shown in items 12 and 14).

There are no capital/start-up costs or ongoing operations and maintenance costs associated with this information collection.

7. Provide an estimate of annualized cost to the federal government.

The estimated cost to the Federal Government is $555.

7. Explain the reasons for any program changes or adjustments reported in items 13 or 14 of the OMB form 83-I.

This is a new Generic IC.

7. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

The primary use of epidemiologic data will be to provide information necessary for controlling an animal health outbreak or other animal health emergency in order to prevent the loss of livestock. Data may be used after an event in presentations or academic/journal articles. Data analysis will be performed primarily by NAHMS staff; however State, local, academic, and industry representatives may be involved,as needed. Any publication of data derived from this epidemiological study may be subject to review by these parties. Any published data will be available at http://www.aphis.usda.gov/animal_health/nahms/index.shtml.

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

Not applicable. APHIS will display the expiration date.

7. Explain each exception to the certification statement identified under “Certification for Paperwork Reduction Act.”

APHIS is able to certify compliance with all provisions in the Act.

1 The National Animal Health Monitoring System is responsible for collecting national data on animal health and productivity from voluntary participants.

2 United States Code § 391, and 7 U.S.C. § 8308 are available upon request.

Page 7