Part A of the Supporting Statement

SUPPORTING STATEMENT FOR INFORMATION COLLECTION

UNITED STATES DEPARTMENT OF AGRICULTURE (USDA)

ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

VETERINARY SERVICES (VS)

CENTER FOR EPIDEMIOLOGY AND ANIMAL HEALTH (CEAH),

NATIONAL ANIMAL HEALTH MONITORING SYSTEM (NAHMS)

NAHMS Emergency Highly Pathogenic Avian Influenza Epidemiologic Investigation

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

NATIONAL ANIMAL HEALTH MONITORING SYSTEM (NAHMS)¹

OMB NUMBER 0579-0376

NAHMS Emergency Epidemiologic Investigations

April 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 0579-0376 in response to the introduction of highly pathogenic avian influenza (HPAI) to commercial poultry operations in the United States. The purpose of this investigation is to assess potential pathways of initial introduction of HPAI viruses onto commercial poultry operations and potential lateral transmission routes of HPAI viruses from infected premises to noninfected premises. NAHMS staff has created, with assistance from Veterinary Services personnel, a standardized assessment to identify potential pathways of initial virus movement onto the farm and potential movement of the virus off the farm. Questions include those associated with biosecurity and employee work assignments, farm equipment, litter handling, dead bird disposal, farm visitors, and wild bird contact.

Due to the unpredictable nature of the introduction of HPAI onto commercial operations, the number of respondents presented below is our best estimate of the maximum number of respondents.

• Approximately 60 infected poultry operations will be surveyed.

• Approximately 120 noninfected poultry operations will be surveyed.

Information collected in this investigation will be used to:

1. Assess potential pathways of initial introduction of HPAI viruses onto commercial poultry operations

2. Assess potential lateral transmission routes of HPAI viruses from infected premises to noninfected premises.

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. Highly pathogenic avian influenza is not endemic in the United States and is considered a foreign animal disease. State and Federal animal health officials will use the information to understand the extent to which HPAI has been introduced to commercial poultry operations and identify potential lateral transmission routes to noninfected premises. Data will also be used to develop control strategies. 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 by multiple State animal health officials 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 will be used to collect the information from respondents. No other information technology will be used.

3. Describe efforts to identify duplication.

This situation is unique and the information needed is specific to the circumstances with this outbreak. VS is working in collaboration with state departments of agriculture to ensure efforts are not duplicated and uniform data is collected across states.

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

The survey has been designed to collect the minimum amount of data required to respond to the outbreak. 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.

This information collection is consistent with the guidelines established 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. Linda Glaser

Minnesota Board of Animal Health

625 Robert St N.

St. Paul, MN 55155

(651) 296-2942

(651) 296‐7417 fax

[email protected]

Beth Thompson

Minnesota Board of Animal Health

625 Robert St N.

St. Paul, MN 55155

(651) 201-6844

(651) 296‐7417 fax

[email protected]

Dustin Oedekoven, DVM
State Veterinarian

411 South Fort Street
Pierre, South Dakota 57501
Phone: 605-773-3321
Fax: 605-773-5459

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.

This information is not being collected under the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA). 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.

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.

1. A total of 181 burden hours are needed to complete this emergency epidemiologic investigation. A detailed burden estimate has been included on the APHIS 71.

2. Respondent costs: Estimated respondent costs for the information collection proposed are calculated based on a data collection estimate of $15 per hour. The total respondent cost for performing emergency epidemiologic assessments is $2,715 (181 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 $8,626. For more specific information, please see APHIS 79.

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 being added to this information collection.

16. 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 will 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.

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

APHIS will display the expiration date.

16. 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.

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