2013 ss

SUPPORTING STATEMENT 0579-0327

ANIMAL DISEASE TRACEABILITY

April 2014

Terms of Clearance:

“In accordance with the terms of 5 CFR 1320, OMB approves this ICR for a period of 3 years. In its Supporting Statement, the Agency says that all forms associated with this collection will be available electronically in 3 years. The Agency should ensure that this is accomplished before resubmitting this collection to OMB.”

VS form 1-63 which was previously the only form in this information collection is now fillable and available online. APHIS form 453-R is new to this information collection and is fillable and will be posted on the Web upon OMB approval of this information collection.

NOTE: The title of this information collection changed. It was previously titled – “Animal Disease Traceability: Tribal Nations Using Systems for Location Identification.” Now, it is titled - “Animal Disease Traceability.” This new title better represents this information collection now that several burden items are being added.

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict the import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease.

The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002.

USDA has had various programs that provided animal identification and traceability. Historically, disease programs achieved adequate levels of identification to meet traceability needs. As certain diseases have neared eradication, participation in those programs had decreased; thus, USDA needed other methods to maintain traceability.

On February 5, 2010, USDA announced it would develop a new, flexible framework for animal disease traceability in the United States, and undertake several other actions to further strengthen its disease prevention and response capabilities. USDA decided to offer a new approach to animal disease traceability after concluding national listening tours on the National Animal Identification System (NAIS).The changes responded directly to the feedback.

The framework provides the basic tenets of an improved animal disease traceability capability in the United States and:

• Only apply to animals moved in interstate commerce.

• Are administered by the States and Tribal Nations to provide more flexibility.

• Encourage the use of lower-cost technology.

• Are implemented transparently through Federal regulations and the full rulemaking process.

USDA adapted these tenets for animal disease traceability while using investments previously made in the NAIS on information systems, official animal identification devices, and other areas where States and Tribes had achieved progress through cooperative agreements. This information collection supports the Animal Disease Traceability framework (including National Uniform Eartagging System (NUES) and roadmaps) and combines activities formerly covered in this information collection.

The traceability program remains essential in helping animal health officials protect U.S. livestock and poultry from disease spread and retaining access to domestic and foreign markets. Timely response to disease outbreaks will:

• Slow disease spread and reduce associated economic impact.

• Lessen disruption to producers and animal owners.

• Speed lifting of quarantine and movement restrictions.

• Lessen the likelihood of animal depopulation.

• Increase consumer confidence.

Within the ADT framework, NUES gives a nationally unique identification number for animals that need official identification. To distribute and use official identification eartags using the NUES, APHIS requires several information collection activities such as:

1. Eartag orders

2. Program Site Tag Information Sheet (APHIS Form 453-R)

3. Record of tags issued and applied and recordkeeping

4. Coordination of tag orders with manufacturers and recordkeeping

5. Reporting loss, theft, or misuse of NUES tags

6. Removal or replacement of eartags and recordkeeping

7. Record of tags applied and recordkeeping

8. Informing VS of tag orders

9. Tribe tag distribution

10. Dairy Herd Information Association (DHIA) eartag distribution plan

11. DHIA tag application record

APHIS makes some systems available to tribes. Tribes can designate which premises registration information system they would like to use, if any, by completing VS 1-63, Tribal Location Identification System Implementation Request. The form states what system the Tribes want to use, if any, and lets APHIS know how to help the Tribes use the system.

APHIS is asking OMB to approve, for 3 years, of its use of these information collection activities in connection with its efforts to carry out traceability and the ADT framework.

2. Indicate how, by whom, how frequently, 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.

APHIS will use the following information collection activities to carry out an effective animal traceability program.

ANIMAL DISEASE TRACEABILITY (ADT) ROAD MAP

Develop ADT Roadmap using templates

Submit ADT Roadmap for approval

The ADT Road Map is intended to serve as a strategic 3-year plan for advancing animal disease traceability within the jurisdiction of each State, Tribe, or territory. Each applicant must prioritize its program objectives and needs according to its traceability capability. By forecasting objectives and needs by 3 years, applicants can plan more consistently year to year and substantially reduce the time involved in planning and developing annual cooperative work plans. Concurrently, APHIS will have collective information to better project and enhance justification and submission of annual Federal budget requests and associated accountability.

APHIS has developed an ADT Road Map template as well as the basic tenets of a strategic plan outline. The Road Map must be approved by VS Regional personnel and filed in the Eastern and Western Regional Offices. The regions will approve the Road Maps using a checklist addressing the items in the Table of Contents.

Each applicant may address each item or add to the Road Map in a way that will benefit its own traceability needs. The template includes six required items that directly support the implementation framework and measure national traceability capability:

1. The applicant must list at least four animal disease traceability performance measures.

2. The applicant must indicate intended use of official metal ear tags to be applied by persons other than State or Federal animal health officials or accredited veterinarians.

3. The applicant must identify its tag distribution recordkeeping system(s).

4. The applicant must identify how and when animal disease traceability data will be shared with other States, Tribes, territories, and APHIS.

5. The applicant must describe an outreach plan that explains its traceability plan and the ADT Road Map to accredited veterinarians, livestock markets, and industry, including small producers and those in underserved areas.

6. The applicant must describe a plan to monitor the activities described in the Road Map and to report interstate movement activity. This plan must include:

a. The number of interstate certificates of veterinary inspection (ICVIs) and other interstate movement documents created within the State, Tribe, or territory.

b. The number of ICVIs and other interstate movement documents received for animals moved into the State, Tribe, or territory.

c. The number of animals by species and class moving into the State, Tribe, or territory, indicating the number of animals officially identified and the number not officially identified.

d. The number of animals by species and class moving out of the State, Tribe, or territory.

e. Volume of distribution for each official numbering system used or device issued, including backtags.

The ADT Road Map will prioritize implementation objectives. Annual cooperative work plans will be developed from this list of prioritized objectives. This is intended to provide consistency and transparency in implementing this new approach to animal disease traceability.

USE OF NUES EARTAGS: GENERAL PROVISIONS

Eartag Orders

To obtain NUES eartags from USDA through the VS supply warehouse, the State, Tribe, or accredited veterinarian, will need to provide the designated VS order taker their mailing address and the number of tags they are ordering. Tag orders may be placed by telephone, fax, or mail. Orders may also be placed online; the next item covers orders placed over the Internet. Because VS uses tag information to trace animals during disease events, NUES tags are accountable property. Those who distribute, receive, and apply them must maintain appropriate records as described below and keep the tags in a secure place before applying them.

Program Site Tag Information Sheet (APHIS Form 453-R)

Users will also be able to order NUES eartags through the National Logistics Support Center Web site operated by the National Oceanic and Atmospheric Administration using APHIS form 453-R. Users will be able to obtain this form online. The form asks requestors to provide their shipping address, the date of the request, a telephone number, the type and number of tags requested, and yearly usage. Once the supply warehouse receives the form, the requestor receives account access with a user ID and password, and can then use the site to order tags.

Record of Tags Issued and Applied and Recordkeeping

Federal employees of the VS supply warehouse keep a record of tags issued to States and Tribes, and States and Tribes also must keep records of tags issued to accredited veterinarians, field employees, and producers. Accredited veterinarians will also apply tags and keep records in the course of disease program work. The recordkeeping ensures accountability in the distribution system so that tags can be quickly matched to animals during a disease event. The records may be electronic or paper-based depending on the volume of tags and the needs of the State or Tribe. States and Tribes (and accredited veterinarians as appropriate) must collect sufficient contact information about the NUES tag recipients to meet the traceability needs of the State or Tribe, which in turn ensures that not only State but Federal animal health officials have the traceability information needed for disease control, eradication, and surveillance efforts. At a minimum, the record must include:

1. The name of the person receiving the tags.

2. The street address, city, State, and ZIP code where the tags are distributed.

3. The identification numbers issued.

4. The date the tags were issued.

5. The name and contact information of the person issuing the tags.

States and Tribes will need to maintain a record of NUES eartags issued for a minimum of

5 years to support Federal animal disease tracing ability.

Coordination of Tag Orders with Manufacturers and Recordkeeping

States and Tribes (as well as Dairy Herd Information Association members) may choose to purchase their own tags and not use the free ones available from VS. If so, they will need to make sure that the manufacturer and tags are APHIS-approved and that the number sequence is carefully coordinated with the manufacturer to avoid duplicate tag numbers. States and Tribes will also need to maintain a record of these NUES eartags, including all contact and issuance information, for a minimum of 5 years to support Federal traceability efforts.

Reporting Loss, Theft, or Misuse of NUES Tags

VS personnel, State and Tribal animal health officials and their staffs, and accredited veterinarians who use NUES tags for program work must report loss, theft, or misuse of NUES tags to the AVIC. This ensures that no one uses tags fraudulently or in a manner that would prevent VS’s ability to accurately trace the animal to which the tag was applied. Producers are encouraged to report, but are not required to do so. VS does not have an established reporting method, but the following information, at a minimum, should be reported:

1. Name and address of the reporting individual.

2. The tag numbers of lost, stolen or misused tags.

3. The date of the occurrence.

4. A description of what happened.

Removal or Replacement of Eartags

If an eartag has to be removed, the State or Tribal animal health official or accredited veterinarian will record in a manner that meets State or Tribal needs the date the device is removed, contact information (address and phone number) for the location at which the device is removed, the official number of the device being removed, device type, reason for removal, the new identification number, and the type of replacement tag. The information will support VS’ ability to trace animals during a disease event. For that reason, VS requires that the records be retained for 5 years.

 

USE OF NUES EARTAGS IN OFFICIAL DISEASE PROGRAM ACTIVITIES

Record of Tags Applied (Recordkeeping)

State and Tribal animal health officials and accredited veterinarians using NUES tags for official disease program work must record and make available to VS sufficient contact information about where the eartags are applied (not just the person to whom they are issued) to meet the traceability needs of the State or Tribe. This ensures that not only State but Federal animal health officials have the traceability information needed for disease control, eradication, and surveillance efforts. At a minimum, the record must include:

1. The name of the owner of the livestock operation where the tags are applied.

2. The street address, city, State, and ZIP code where the tags are applied.

3. The identification numbers applied.

4. The date the tags were applied.

5. The name and contact information of the person applying the tags.

6. If the State or Tribe uses the AIMS to record tag application records, the record must include a premises identification number or State location identifier.

The operation owner names and addresses are drawn from existing information collected by the States and Tribes for disease program purposes and do not need to be collected separately when tags are applied. The person who applies the tags for disease control programs will be a State, Tribal, or Federal animal health official, who would only have to provide the date the tags were applied.

NUES EARTAGS DISTRIBUTED OUTSIDE OF DISEASE PROGRAMS

State and Tribal animal health officials may provide NUES eartags to producers who wish to use them for official identification and other purposes without administering the eartags through a specific disease program. This lets producers use the eartags to qualify their animals for interstate movement under the ADT framework. Distribution of tags is conducted in a way that meets local needs and resources. State or Tribal animal health officials will always oversee the integrity of the information collected when NUES tags are distributed outside of specific disease programs.

To comply with the ADT framework, and ensure that APHIS has adequate data to trace animals, State and Tribal animal health officials must conduct the following information collection or recording activities:

Informing VS of Tag Orders

VS needs to know which States and Tribes wish to distribute tags to producers so that it can make enough tags available and can budget accordingly. States and Tribes need to let VS know which numbering format they wish to use because the number-prefixed tags are purchased directly by VS, and the alpha-prefixed tags are purchased by the States and Tribes. The State or Tribal designated official lets the AVIC know that the State or Tribe wishes to distribute tags and the AVIC reports the information to a member of the VS animal traceability staff.

Tribe Tag Distribution

Tribes will need to inform VS which of the following options they will use to issue tags so that their sovereign decision is clear:

1. Obtaining NUES eartags through the State in which the Tribe is located, and working with the State to maintain records as set forth under the general provisions section of this collection.

2. Obtaining NUES eartags through the appropriate VS Area Office, and working with the Area Office to maintain records as set forth under the general provisions section of this collection.

3. Issuing Tribe-specific NUES eartags to Tribal producers, and maintaining records according to the needs of the Tribe.

USE OF NUES EARTAGS IN THE DAIRY HERD INFORMATION ASSOCIATION (DHIA)

DHIA Eartag Distribution Plan

Each State or Tribe where DHIA has tag distribution must have an eartag distribution plan prepared, agreed to, in writing, and signed by the AVIC, the State or Tribal animal health official, and the State DHIA representative. The information in the plan coordinates DHIA tag use with Federal traceability information needs. The plan will set aside a block of numbers for cattle to be identified, a description of the current recordkeeping system, and a description of the DHIA responsibilities for maintaining a database of all DHIA eartag numbers. The plan will also set forth methods for recording information about the herd to which the eartags are applied or distributed to meet the traceability needs of the State or Tribe where the animals are identified. The AVIC, the State or Tribal animal health official, and the State DHIA representative, as well as the tag manufacturer, each receive a copy of the plan.

VS 1-63, Tribal Location Identification System Implementation Request

Tribes can designate which premises information system they would like to use, if any, by completing VS 1-63. The form states what system the Tribes want to use, if any, lets APHIS know how to help Tribes in using the system. APHIS will use the information provided on VS 1-63 to contact the respondents and help them use the premises information system they selected. APHIS will access this information only once to initiate the process. The information also helps ensure that when multiple parties claim to represent Tribes in managing location identification information, USDA only deals with those entities the Tribe has officially recognized.

Recordkeeping for VS 1-63

The Tribal organization will retain the VS 1-63 for 3 years to answer any inquiries concerning which system the Tribe is using.

DHIA Tag Application Record

DHIA will record, in a database, the identification tag numbers when the animals are identified (or when tags are issued to producers to apply) and information about the herd in which the eartags are issued or applied. The record should include sufficient information about the location where NUES eartags are distributed or applied to meet the traceability needs of the State or Tribe and ensure that not only State but Federal animal health officials have the traceability information needed for disease control, eradication, and surveillance efforts. At a minimum, the record must include:

1. The name of the owner of the herd where tags are issued or applied.

2. The street address, city, State, and ZIP code of the livestock operation where the animal identification tags are issued or applied.

3. The official identification numbers issued to the producer or applied to the animals.

4. The date the tags are issued or applied.

5. Name and contact information of the person who issued or applied the tags.

6. If the State or Tribe uses the AIMS to enter tag distribution records, a premises identification number or State location identifier is required.

The herd owner names and addresses are drawn from DHIA’s member database and do not need to be collected separately when tags are issued. If a DHIA field representative applies the tags, he or she would only have to provide the date the tags were applied and the official identification numbers used. If the tags are provided to the producer to apply, the DHIA field representative would only need to provide the date the tags were issued and the official identification numbers. The producer has no recordkeeping or reporting responsibility.

The DHIA must keep records of the numbers for a minimum of 5 years after the eartags are applied, as the records are critical in helping VS determine the origin of animals during a disease investigation. DHIA representatives must also send a report to VS at least monthly. The report must include the information that DHIA records when tags are issued or applied.

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 nresponses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The Road Map template will be used as a guide for the States, Tribes, and territories to complete their Road Map. The Road Maps will be developed using standard word processing software (e.g., MS Word) and submitted on paper to the VS regional offices or by attaching an electronic document to an email directed to the VS regional offices.

We do not currently have an automated system to evaluate the Road Maps. As we collect baseline traceability implementation data over the next several years, we expect to have the necessary information to design and implement an electronic evaluation system.

USE OF NUES EARTAGS: GENERAL PROVISIONS

Eartag Orders

Respondents can call, fax, mail, or email orders.

APHIS uses the AIMS for tracking official eartag orders. Although the system was initially designed to track the distribution of 840 (USA country code) Animal Identification Number (AIN) eartags, it is now available to record the distribution of NUES tags. The AIMS is available at no charge to any State or Tribe (or accredited veterinarian) wishing to use it. It is also integrated with approved tag manufacturers. Another option for recording tag distribution is the Surveillance Collaboration Services (SCS) which APHIS is now using to replace the Generic Database. SCS is a commercial off-the-shelf product used to meet most of VS’ data entry needs for animal disease program management.

Program Site Tag Information Sheet (APHIS Form 453-R)

Tags may also be ordered through the National Logistics Support Center Web site operated by the National Oceanic and Atmospheric Administration using APHIS Form 435-R as described below. This form will be available on our APHIS Web site upon OMB approval.

Record of Tags Issued and Recordkeeping

The AIMS must be used to maintain a record of all 840 AIN tags issued from the manufacturer to States, Tribes, tag dealers and resellers, and producers. Whoever has possession of a tag is responsible for recording to whom the tag is delivered up to the point it is issued to a livestock operation. The producer does not need to record anything in the system. The AIMS can also be used to track the issuance of NUES tags, but it is not required to be used for this.

Coordination of Tag Orders with Manufacturer and Recordkeeping

When States, Tribes, or DHIA members choose to order their own tags, they can use their own electronic system or the AIMS.

Reporting Loss, Theft, or Misuse of NUES Tags

Reporting will most likely be done by telephone or e-mail. Each State or Tribe will determine the best method for accepting reports in a way to preserve the reporter’s anonymity and get accurate information. Privacy concerns preclude using an electronic system.

Removal or Replacement of Eartags and Recordkeeping

Requests to remove or replace tags will most likely be handled by telephone or email. These methods will be easier to administer and will cost less than an electronic database set up solely for this purpose. An electronic database is not justified because VS receives few requests to remove or replace tags.

USE OF NUES EARTAGS IN OFFICIAL DISEASE PROGRAM ACTIVITIES

Record of Tags Applied (Recordkeeping)

The APHIS Mobile Information Management System (MIMS) (fully electronic device) is used at the field level to enter data when animals are processed for disease control programs.

NUES EARTAGS DISTRIBUTED OUTSIDE OF DISEASE PROGRAMS

Informing VS of Tag Orders

Reporting to VS will most likely be done by telephone or email, or as part of the cooperative agreement workplan for traceability.

Tribe Tag Distribution

Reporting to VS will most likely be done by telephone or email, or as part of the cooperative agreement workplan for traceability.

USE OF NUES EARTAGS IN THE DHIA

DHIA Eartag Distribution Plan

The distribution plan is a written document agreed on and signed by State and Federal animal health authorities and the DHIA. Since few of these documents are generated it would not be cost effective to set up an electronic system to monitor and support them.

VS 1-63

VS 1-63 is available on the APHIS Web site. In addition, respondents can request, receive, and submit the VS 1-63 via email or fax.

http://www.aphis.usda.gov/library/forms/pdf/VS_1_63.pdf

DHIA Tag Application Record

The DHIA will have access to MIMS if they want to use it, although DHIA offices have highly automated electronic systems of data recording. Reports to States or Tribes are expected to be in the form of an electronic file transmitted in a way most appropriate for local needs, such as an e-mail attachment or Internet data transfer. The DHIA data processing centers are capable of long-term electronic data storage; no additional systems are needed.

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

APHIS has exclusive responsibility for implementing the ADT system as it is the only Federal agency responsible for tracing animal disease outbreaks.

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

The information APHIS collects for this program is the minimum needed to protect U.S. livestock and poultry from the spread of disease. APHIS estimates that 75 percent of the total respondents are small entities.

5. 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.

If the information was collected less frequently or not collected, APHIS would be unable to effectively detect disease in the U.S. livestock population, to prevent disease spread within the United States, and to eliminate certain animal diseases from the United States.

5. Explain any special circumstances that require the 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;

APHIS requires monthly reporting of DHIA tag application records because animal diseases can affect all ages and classes of livestock, and the ability to quickly find animals of interest is essential to effective disease control. APHIS provides an electronic database to record tag distribution information when tags are distributed, but use of this system is not required. DHIA centers that wish to use their own systems may do so if they forward application and distribution records to VS at least monthly to provide the information needed for rapid disease response.

• 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;

APHIS requires retention of NUES identification device issuance records, DHIA tag application records, and reports of removed or replaced tags for 5 years. This requirement is based on the fact that livestock animals, especially cattle, typically live to be more than 3 years old and that animal diseases can affect all ages and classes of livestock. Therefore, traceability information that fully supports disease control, eradication, and surveillance needs to be maintained for longer than 3 years so that animals can be found quickly for effective disease control. The 5-year requirement brings consistency throughout our regulations.

• 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 other 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.

5. 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.

APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this project:

Dr. David D. Schmitt

Iowa State Veterinarian

Animal Industry Bureau

Agriculture & Land Stewardship

502 East 9th Street

Des Moines, IA 50319

Phone: 515-281-5305

Fax: 515-281-4282

Email : [email protected]

Dr. Kristin M. Haas

Vermont State Veterinarian

Vermont Department of Agriculture

116 State St.

Montpelier, VT 05602-2901

Phone: 802-828-2426

Fax: 802-828-5983

Email : [email protected]

Vicky LeBeaux

Intertribal Agriculture Council

100 North 27^th Street

Suite 500

Billings, MT 59101

Phone: 406-259-3525

Fax: 406-259-9980

Email: [email protected]

On Tuesday, February 25, 2014, pages 10470-10471, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. During that time, 0 comments were received.

5. Explain any decision to provide any payment or gift to respondents, other than

remuneration of contractors or grantees.

This information collection activity involves no payments or gifts to respondents.

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

No additional assurance of confidentiality is provided with this information collection. However, the confidentiality of information is protected under 5 U.S.C. 552a.

5. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or 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.

This information collection activity will ask no questions of a personal or sensitive nature.

5. 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.

• 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.

See APHIS Form 71. Burden estimates were developed from discussions with State and Tribal animal health authorities; producers; non-producer participants such as accredited veterinarians, designated laboratories, and AIN device managers; and owners and operators of feedlots, markets, buying stations, and slaughter plants.

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

APHIS estimates the total annual cost to these respondents to be $20,477,844. APHIS arrived at this figure by multiplying the total burden hours (839,600) by the estimated average hourly wage of the above respondents ($24.39) from the U.S. Department of Labor.

The average hourly rate is derived from the U.S Department of Labor; Bureau of Labor Statistics May 2013 Report – National Compensation Survey: Occupational Employment and Wages, May 2012. See http://www.bls.gov/oes/#tables.

State animal health officials and accredited veterinarians: $44.83 (veterinarians)

Animal producers, market/buying station operators, and feedlot operators: $35.45 (first-line supervisors of farm workers/ Farm, ranch, and other agricultural managers)

Device manufacturers: $23.39 (computer numerically controlled machine tool programmers)

Slaughter plant personnel: $11.99 (slaughters and meat packers)

(Staff of State and Tribal animal health officials; DHIA employees) Agricultural and food science technicians - $17.49

(Staff of State and Tribal animal health officials) Agricultural inspectors - $20.41

(Eartag manufacturers and distributors) First-line supervisors/managers of production and operating workers - $27.61

(Eartag manufacturers and distributors) Assemblers and fabricators, all others - $13.98

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

No annual cost burden is associated with capital and startup costs, operation and maintenance expenditures, and purchase of services.

5. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

The annualized cost to the Federal Government is estimated at $86,266 (see APHIS Form 79).

5. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	2,757,105	0	2,757,055	0	0	50
Annual Time Burden (Hr)	839,600	0	839,569	0	0	31
Annual Cost Burden ($)	0	0	0	0	0	0

The overall burden for this information collection increased by 2,757,055 responses and 839,569 total burden hours due to Program Changes. Note: Of the 2,757,055 responses, 2,755,419 are due to Potential Violations , and of the 839,569 program change hours, 838,881 hours are due to Potential Violations of the PRA. USDA is not able to reflect the Potential Violations of the PRA hours in ROCIS.

APHIS added the following activities to this information collection to better carry out the traceability program (New/Program Changes):

Develop ADT Roadmap using Template (+432 hours)

Submit ADT Roadmap for approval (+ 14 hours)

Program Site Tag Information– APHIS form 453-R (+2 hours)

Reporting Loss, Theft, or Misuse of NUES Tag (+ 110 hours)

Removal or Replacement of Eartag (+ 100 hours)

Informing VS of Tag Orders (+ 5 hours)

Tribe Tag Distribution (+ 25 hours)

In addition, in the past 2 years APHIS started collecting information on the following activities that were not previously approved, so APHIS is a requesting OMB approval of them now (Potential Violations of the PRA):

Eartag Orders (+341,809 hours)

Record of Tags Issued and Applied and Recordkeeping (+ 414,369 hours)

Coordination of Tag Order with Manufacturer and Recordkeeping (+ 47 hours)

Record of Tags Applied and Recordkeeping (+ 15,120 hours)

DHIA Eartag Distribution Plan (+100 hours)

DHIA Tag Application Record (+ 67,436 hours)

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

APHIS has no plans to publish information it collects in connection with this program.

5. 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.

5. Explain each exception to the certification statement identified in the "Certification for Paperwork Reduction Act."

APHIS can certify compliance with all provisions of the Act.

2. Collections of Information Employing Statistical Methods

No statistical methods are associated with this information collection.

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