2013 Ss 0047

SUPPORTING STATEMENT - OMB NO. 0579-0047

BRUCELLOSIS PROGRAM

April 25, 2012

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 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.

Disease prevention and disease surveillance are the most effective methods for maintaining a healthy animal population and for enhancing the United States’ ability to compete in the world market of animal and animal product trade. The Veterinary Services (VS) unit of the USDA’s Animal and Plant Health Inspection Service (APHIS) is responsible for administering regulations intended to protect the health of the U.S. livestock population.

Brucellosis is an infectious disease of animals and humans caused by bacteria of the genus Brucella. The disease is characterized by abortions and impaired fertility in its principal animal hosts. The disease infects humans through contact with infected animals or with certain body fluids of infected animals. Usually Brucella abortus is associated with the disease in cattle or bison, Brucella suis with the disease in swine, and Brucella melitensis with the disease in sheep and goats. The continued presence of brucellosis in a herd seriously threatens the health, welfare, and economic viability of the livestock industry. There is no economically feasible treatment for brucellosis in livestock.

The Cooperative State-Federal Brucellosis Eradication Program is a national program to eliminate this serious disease of livestock. The program is conducted under the authority of the various States, supplemented by Federal authorities regulating interstate movement of infected animals. Regulations in title 9, Code of Federal Regulations, (9 CFR) part 78 outline the Cooperative State-Federal Brucellosis Eradication Program. These rules stipulate the necessary surveillance, epidemiologic investigation, annual reporting, and interstate movement activities that must be documented.

Minimum program standards known as the Brucellosis Eradication Uniform Methods and Rules (UM&R) are developed cooperatively by organizations representing the livestock industry, State animal health agencies, and USDA. Recommendations for changes to the program standards are most commonly submitted by industry or State stakeholders consideration and approval by USDA. If the recommendations are accepted as part of the program standards, the UM&R is amended to incorporate the change.

State and Federal officials in charge of program activities in each State are responsible for continuously evaluating the efficiency of local procedures in locating and eliminating infected livestock. The minimum standards in the UM&R must be met or exceeded throughout the certification period to maintain continuous status. Meeting these standards requires providing information on the following forms:

VS 1-23: Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed

VS 1-23A: Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed, Continuation Sheet

VS 1-27: Permit for Movement of Animals

VS 4-1: Application for Brucellosis Classification or Reclassification of State

VS 4-1D: Application for Validation of a Brucellosis-Free Area

VS 4-6: Justification for Brucellosis Herd Depopulation

VS 4-7: Agreement for Complete Herd Depopulation – Brucellosis

VS 4-13: Certified Herd – Cooperative Brucellosis Eradication:

VS 4-24: Calfhood Vaccination Record – Short Form

VS 4-26: Vaccination Record – Long Form

VS 4-33: Brucellosis Test Record

VS 4-33A: Brucellosis Test Record Continuation Sheet

VS 4-33D: Monthly Report of Brucellosis Eradication Activities

VS 4-34: Cooperative State-Federal Brucellosis Eradication Program, Brucellosis Test Record

VS 4-38: Brucellosis Ring Test Rack Chart

VS 4-39: Brucellosis Ring Test Patron List

VS 4-39A: Patron List – Cooperating

VS 4-52: Report of Backtags Applied

VS 4-52A: Report of Backtags Applied, Continuation Sheet

VS 4-54: Brucellosis Test Record Market Cattle Testing Program

VS 4-54D: Monthly Report of Brucellosis Program Surveillance Activities

VS 4-59: Quarterly Report of Swine Brucellosis Eradication Activities

VS 4-80: Application for Validated Brucellosis-Free Herd Certification

VS 4-100: Log for Market Cattle Test Reactors

VS 4-106: Field Investigation of Brucellosis Market Test Reactors

VS 4-108: Epidemiological Investigation of Brucellosis Reactor Herd

VS 4-108A: Origin of Reactors/Herd Additions

VS 4-108B: Animals Removed from Infected Herds

VS 4-108C: Epidemiological Report – Area Herds

Certificate of Veterinary Inspection (CVI)

The information is generally collected by State and Federal animal health officials through interviews or reviewing records. The information on some documents may be collected by private veterinary practitioners (i.e., test charts, vaccination records, and official Certificates of Veterinary Inspection) or blood collection personnel on contract (i.e., market cattle slaughter surveillance blood collection forms and brucellosis ring testing milk sample collection forms).

The information is collected at the time each appropriate event occurs. In most instances, information is collected at the time of testing or vaccinating individual animals or herds, applying official identification to animals, or conducting surveillance or epidemiologic investigation activities. Some events, such as market cattle slaughter surveillance, occur daily. Other events, such as on-farm blood testing and vaccinating, occur as part of routine animal health management. A few events, such as infected herd investigations, occur perhaps only a few times a year.

APHIS uses the information to demonstrate that program requirements are being met for State and herd status. APHIS also uses the information to demonstrate that program-allowed activities, such as testing, vaccinating, and movement, are being conducted in accordance with program rules.

APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities in connection with APHIS’ efforts to eradicate brucellosis from the United States.

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 uses the information to demonstrate that program requirements are being met for State and herd status and to demonstrate that program-allowed activities, such as testing, vaccinating, and movement, are being conducted in accordance with program rules.

Forms

Application for Brucellosis Classification or Reclassification of State (VS 4-1)

This form documents State or area status for bovine brucellosis. States are classified annually. This form is prepared by the Designated Brucellosis Epidemiologist (DBE), using data gathered from the Automated Web Based Data Submission (AWBDS) database and reports compiled and provided by other State and Federal program personnel. The completed VS Form 4-1 is then reviewed and signed by the State veterinarian and Area Veterinarian in Charge (AVIC), and submitted for review and approval by the regional brucellosis epidemiologist and the brucellosis program manager.

The form requires the following information so that the State can be classified appropriately:

• The name of the State or the area

• Type of request (advancement or continuation of status) and regulation reference

• General information regarding herd and cattle population statistics and the reporting period dates

• Brucellosis field blood testing summary information for Market Cattle Identification (MCI) reactor and brucellosis ring test epidemiological investigations, including numbers of herds and cattle tested and results of these blood tests, including number of reactor animals and infected herds identified

  • Brucellosis surveillance testing summary information for brucellosis ring testing and MCI surveillance, including numbers of herds and cattle eligible for surveillance testing

  • Summary information and statistics by case closure categories for reactor animals

  • Summary information for other species of domestic animals blood tested

Application for Validation of a Brucellosis-Free Area (VS 4-1D)

This form documents State or area brucellosis status for swine brucellosis. States or areas are validated every 3 years. It is prepared by the DBE, reviewed and signed by the State veterinarian and AVIC, and reviewed by the regional brucellosis epidemiologist and the brucellosis program manager for a recommendation to approve or disapprove the application. The form requires the following information so that the area can be approved as a validated brucellosis-free area:

• The name of the State, status applied for, and qualifying method

• Complete herd (area) testing summary information, including numbers of herds and swine tested and number of validated swine brucellosis-free herds

• Market swine testing summary information, including numbers of samples tested from collection at first points of concentration and slaughter, and numbers of breeding swine slaughtered

• Summary information for blood samples collected and tested for diagnostic, sale, and other purposes

• Summary information for combined surveillance

• Summary information for Market Swine Test (MST) reactors, including total number of MST reactors, number traced, and number not traced

• Range of dates of testing for the application period

• Brief narrative of swine brucellosis status of the State, including identification and disposition of last infected animal.

Certified Herd – Cooperative Brucellosis Eradication (VS 4-13)

This form documents brucellosis herd status for cattle and bison. Certified herds are recertified annually. This form is prepared by the DBE and reviewed and signed by the State veterinarian and AVIC. The form includes the following information:

• Name of State and owner’s name and address

• Number and description (type) of animals in the herd

• Herd certification period ending date

Application for Validated Brucellosis-Free Herd Certification (VS 4-80)

This form documents brucellosis herd status for swine brucellosis. Validated swine herds are revalidated annually. The form is prepared by the DBE and reviewed and signed by the herd owner, the State veterinarian, and the AVIC. It includes the following information:

• The herd owner’s name and address, including geographic location information

• The size of the breeding herd and herd inventory (number of males and females)

• Listing of the qualifying herd tests and summary of herd test results

Monthly Report of Brucellosis Eradication Activities (VS 4-33D)

Monthly Report of Brucellosis Program Surveillance Activities (VS 4-54D)

These forms are now filed electronically each month by the State and VS Area Office and record, for APHIS’ review and program evaluation purposes, the eradication and surveillance activities occurring each month in the State. The VS 4-33D contains the following information:

• The State name, area, and class

• The blood tests administered to cattle tested on farms or ranches, categorized by the reasons for each test

• Summary of calves and cattle vaccinated

• Summary of herds pending test or retest

• Summary of herds certified or recertified

• Summary of testing of brucellosis reactor herds in the State, including herd identification, county location, and numbers of animals eligible for test, numbers tested, numbers of reactors, and quarantine and vaccination status of the reactor herds

The VS 4-54D contains the following information:

• Summary information for blood tests on market cattle originating in the State, including testing location, identification, and whether the cattle were reactors

• Summary information for blood tests on market cattle originating in other States that were tested in the State

• A summary of cattle tested at farms or stockyards also tested at slaughter

• A summary of blood sample collections at slaughter by VS personnel or contractors

• Summary information for traceback of market cattle reactors

• Summary information for brucellosis milk and cream ring tests

• A summary of brucellosis tests in other species

• Summary information for monthly report of brucellosis reactor herds/lots in other species

This information is now collected and managed by the Automated Web-Based Data Submission (AWBDS) database. This database allows computer entry of needed brucellosis information obtained from existing records. The computerization of these brucellosis records (test charts, vaccination records, brucellosis ring test, and market cattle identification (MCI) records) allows for electronic entry, at the Area office level, of cattle and swine herd test and MCI test charts. The database thus provides information APHIS needs for program management leading to brucellosis eradication.

Quarterly Report of Swine Brucellosis Eradication Activities (VS 4-59)

This form is used for swine brucellosis program planning and in preparing national statistics and reports regarding the progress of the national swine brucellosis program. This form is prepared by the DBE, using data gathered from the AWBDS database and reports compiled and provided by other State and Federal program personnel. The completed form is then reviewed and signed by the State veterinarian and AVIC, and submitted for review and approval by the regional brucellosis epidemiologist and the swine health program manager. The form requires the following information to be submitted on a quarterly basis:

• Name of State, stage of program, and date (month/year)

• Summary data for samples collected at markets and slaughter establishments to include number of sows and boars tested and number of reactors and suspects, for farm of origin samples collected in the reporting State, and for farm of origin samples collected in other States

• Summary data for traceback of MST reactors and suspects, reported by numbers traced to known infected herds, traced and complete herd tests required, traced and complete herd test not required, traced to dealers, traced to other States, unable to trace, and test results pending

• Summary data for on-farm testing as broken out by reason for test (tracebacks, diagnostic, epidemiology, surveillance, validated herd, and change of ownership) and to include numbers of herds tested and number of swine tested when no infection was found and when infection was found

• Summary data for sources of new herd infections; data reflects number of new herds infected by purchased swine, exposure to feral swine, community spread, unknown source, or other source

• Summary data for swine brucellosis infected herds in the State to include numbers of herds under quarantine, new infected herds, and herds released from quarantine

• Summary data for herds depopulated and indemnified

  • Summary information regarding each swine brucellosis-infected herd, to include name and address of herd owner, method of determination and source of infection, results of all testing in the herd since the last report, herd inventory, and plans for eliminating swine brucellosis from the herd.

Brucellosis Test Record (VS 4-33)

Brucellosis Test Record Continuation Sheet (VS 4-33A)

Cooperative State-Federal Brucellosis Eradication Program, Brucellosis Test Record

(VS 4-34)

The forms are prepared by the veterinarian (an accredited veterinarian or State or Federal veterinarian) doing the testing. The VS-approved brucellosis laboratory records the test results on the form. The DBE reviews the form and classifies the animals tested. The DBE compiles the data from this form to prepare Form VS 4-33D (Monthly Report of Brucellosis Eradication Activities). The form is prepared as needed to document brucellosis testing of animals for movement, private sale, show, or exhibition; herd certification; and brucellosis epidemiologic investigations. These forms are used to document on-farm or on-ranch brucellosis testing. They include:

• The herd owner’s name, address, county, herd number, premises ID number, and GPS coordinates

• The reasons for the tests, the type of herd tested, and whether the tests are complete herd tests of all eligible animals

• The individual animal identification and description of each animal tested and the test results

Brucellosis Test Record Market Cattle Testing Program (VS 4-54)

This form documents brucellosis testing at slaughter facilities and livestock markets. The form lists the name and address of the location where samples were drawn. The form is prepared by the individual at the slaughter facility contracted to collect the blood samples or by the veterinarian (accredited veterinarian or State or Federal veterinarian) at the livestock market doing the testing. The VS-approved brucellosis laboratory (identified by name and address on the form) identifies the names and addresses of the animals’ owners and records the test results on the form. The DBE reviews the form and classifies the animals tested. The DBE compiles the data from this form to prepare the VS 4-54D (Monthly Report of Brucellosis Program Surveillance Activities). The form is prepared daily at the slaughter facilities and whenever it is required at the livestock markets.

Report of Backtags Applied (VS 4-52)

Report of Backtags Applied, Continuation Sheet (VS 4-52A)

These forms document the application of MCI backtags at slaughter facilities and livestock markets. They are prepared by a designated slaughter facility individual, a designated livestock market individual, or a State or Federal market inspector. The following information is collected on these forms:

• The name, address, and type of the location where the tags were applied

• The name and job responsibility of the person applying the tags

• Inventory of the tag applied, to include the tag number, date applied, corresponding sales tag number, any brand information, and the herd owner’s name, address, and county

The completed forms are submitted to the appropriate program manager in the State or VS Area office on a daily to monthly basis depending on the number of backtags applied. A data entry clerk enters the date into the appropriate database and files the report for use in brucellosis epidemiologic investigations.

Recordkeeping

Records are maintained by producers, State and Federal animal health agencies, livestock markets, livestock dealers, slaughter establishments, dairy plants, laboratories, animal agriculture agencies, breed registries, and private veterinary practitioners. The information primarily encompasses animal identification, animal location, animal movement, and animal health management activities. In addition, diagnostic testing information is maintained as part of routine surveillance activities as well as disease investigation activities.

Various documents are kept for various lengths of time depending on their purpose. Record retention periods range from 2 years to 10 years. The recordkeeping requirement documents compliance with program regulations and enables APHIS to trace animals for disease epidemiological investigations.

Current animal identification requirements for cattle and swine provide a means for all cattle and swine in interstate commerce to be traced through marketing channels. The regulations require that cattle and swine be identified while in interstate commerce, and that records be maintained showing ownership of the cattle and swine. The types of records normally kept (waybills, bills of lading, dock receipts, and tagging tickets) are records normally kept by the business to properly pay for the livestock after sale. APHIS uses this same information for disease tracebacks.

Brucellosis Ring Test Patron List (VS 4-39)

Patron List - Cooperating (VS 4-39A)

These forms document the dairies in those States required by 9 CFR 78.1, definition of “class free,” (a)(1)(ii)(A)) to collect and test milk samples for Brucellosis Ring Test (BRT) surveillance 2 to 4 times per year. The form lists the plant name, address, and number as well as the patron name, patron address, patron number, herd number, and the test results. It is used by the VS-approved laboratory to ensure the proper testing protocol is followed. The form is prepared by the State or Federal animal identification coordinator in each State who gets the information from the previous report and from the dairy plants and State regulatory agencies overseeing the State dairy industry. The lists are used by the person collecting the milk samples to ensure that milk samples are collected from all listed patrons (dairies) as required. The data is used in preparing the annual VS 4-1 (Application for Brucellosis Classification or Reclassification of State).

Brucellosis Ring Test Rack Chart (VS 4-38)

This form is used by some VS-approved laboratories when performing the BRT. Laboratory technicians prepare the form when milk samples are received for the BRT. The BRT is performed on a milk sample collected from each dairy in those States as required by regulation,

2 to 4 times per year. Information collected on this form includes:

• The name, address, plant number, and grade status of the dairy plant from which the milk samples were collected

• The BRT round number and the date ranges of collection of the individual milk and cream samples from the dairy farms

• The name of the individual collecting the samples, the number of samples collected, and the date the samples were collected from the dairy plant

• The name of the laboratory technician testing the samples, the laboratory sample rack number, and the date the samples were tested

• A “rack” chart to record the arrangement and patron numbers of samples placed in the rack

Calfhood Vaccination Record – Short Form (VS 4-24)

Vaccination Record – Long Form (VS 4-26)

These forms document brucellosis vaccination or reapplication of a brucellosis tattoo. The forms record:

• The name and address of the herd owner; herd number and owner number

• The kind of herd (beef, dairy, or mixed)

• The vaccine used, including serial number and expiration date, and dosage used

• The date of vaccination and vaccination tattoo applied

• Information identifying the cattle vaccinated, including the age, breed, sex, and grade

• Information identifying the veterinarian performing the vaccination

• Information if re-establishing the vaccination status, including the date of re-establishment, when a vaccination tattoo is reapplied

The accredited veterinarian or the State or Federal veterinarian performing the vaccination prepares the form whenever brucellosis vaccination occurs. The form is submitted to the appropriate brucellosis program personnel in the State where the vaccination is performed. The data is entered in the appropriate database and is used in preparing the VS 4-1 (Application for Brucellosis Classification or Reclassification of State) and in epidemiological investigations.

Field Investigation of Brucellosis Market Test Reactors (VS 4-106)

The DBE or appointed State or Federal brucellosis program person or investigating regulatory veterinarian prepares the form as needed and uses the data in preparing the VS 4-1. This form documents the findings of brucellosis epidemiological investigations conducted after finding a brucellosis reactor animal. Information recorded on this form includes:

• Summary information regarding initiation of the investigation, the origin of the test sample, laboratory testing information, and animal backtagging information

• Reactor animal identification information

• Information for tracing to herd of origin

• Herd information

• Summary information for tracing exposed animals

Log for Market Cattle Test Reactors (VS 4-100)

This form is used to summarize the VS 4-106 (Field Investigation of Brucellosis Market Test Reactors). The DBE prepares or updates the form as needed and uses the data in preparing the VS 4-1. The information recorded on the form includes:

• MCI blood sample ID, sample test results, animal identification accompanying the sample, and name of the laboratory where the sample was tested

• The name and address of the consignor of the animal from which the MCI blood sample was collected and total number of cattle in the consignment

• The destination of the reactor cattle in the consignment

• The date of the field investigation, including the date the herd of origin was tested and the result of that herd test

Epidemiologic Investigation of Brucellosis Reactor Herd (VS 4-108)

This form documents information of epidemiological importance when a herd is found to be infected with brucellosis. (VS Forms 4-108A, VS 4-108B, and VS 4-108C, described below, are supplements to this form. These forms are all completed at the same time.) Information recorded on this form is collected by the DBE or assigned State or Federal field veterinarian and includes:

• Name and address of the herd owner and the herd number

• The reason for testing the herd

• Summary herd status information including clinical signs present, vaccination status of the herd, and number and location of other herds under the same ownership or management

• Type of operations, cattle census on the premises, number of susceptible species on the premises, and herd breeding program

• Traceback and contact herd information including possible and probable sources of infection, origins, movement, and sales of animals in the herd, and accompanying documents

• Quarantine and permits information, including names of six nearest herd owners, quarantine, quarantine release, and movement permit requirements

• Documentation of communication with herd owner regarding herd plan and test schedule and documentation of completing other forms in the 4-108 series and remarks

Origin of Reactors/Herd Additions (VS 4-108A)

This form documents the origin of reactor animals and herd additions. Information recorded on this form is collected from the herd owner by the DBE or assigned State or Federal field veterinarian and includes:

• The name and address of the current herd owner, county location, and herd number

• Information identifying the origin of reactors and herd additions, including sources, animal identification and description, and test results

Animals Removed from Infected Herds (VS 4-108B)

This form documents animals removed from the infected herd. Information recorded on this form is collected from the herd owner by the DBE or assigned State or Federal field veterinarian and includes:

• The name and address of the current herd owner, county of location, and herd number

• Information identifying the list of animals sold or otherwise removed from the herd, including sources, animal identification and description, and test status

Epidemiological Report – Area Herds (VS 4-108C)

This form lets APHIS evaluate whether animals have been mingled, and to determine whether other herds in the area need to be evaluated to detect disease spread. It identifies premises with cattle in the vicinity of the infected herd. Information recorded on this from is collected by the DBE or assigned State or Federal field veterinarian and includes a diagram showing the location of infected and other herds in the same vicinity and the following information for each of those herds:

• The name and address of the herd owner, county of location, and the herd number

• Diagram showing location of infected and other herds in the same locality

• The names and addresses of owners of herds in the same vicinity, dates these owners were contacted, and dates herds are scheduled for test or an explanation if no test is required

Permit for Movement of Animals (VS 1-27)

This form documents the movement of brucellosis reactor, exposed, or suspect animals to provide assurance that the animals are not diverted in shipment. This document is prepared, as needed, by an accredited veterinarian or State or Federal veterinarian before the animals are moved. A copy of the form accompanies the animals to their destination. Personnel at the destination acknowledge receipt of the animals. Information recorded on this form includes:

• Name and address of the shipper or consignor, consignee, and owner at the time the disease condition was diagnosed

• State where the VS 1-27 is issued, location of the premises the animals are moved from, the type and purpose of the movement, and the number and species of animals in the shipment

• Disease and classification status of the animals, the herd of origin and of the area of origin

• Transportation vehicle identification, seal number, and vehicle cleaning and disinfection instructions

• Breed, sex, disease brand, and complete identification tag information for each individual animal to be moved in the shipment

• Signature of issuing individual, date and time issued, and expiration date and time

• Owner, shipper, or trucker identification and title

• Location and date animals received, number of animals received, and date slaughtered or quarantined

• Documentation of date and time seals broken and identification of authorized individual

• Documentation of cleaning and disinfection of conveyance vehicle if required

Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed (VS 1-23)

Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed, Continuation Sheet (VS 1-23A)

These forms document appraisal values of the animals and approval of payment to the owners-claimants. They are prepared by the AVIC. The AVIC submits the completed forms to the regional brucellosis epidemiologist or the associate Regional Director for review and approval, then to the brucellosis program manager for processing of the request to transfer funds. Information recorded on these forms includes:

• Date animals or materials to be destroyed are appraised, dates destroyed, and date of cleaning and disinfection.

• The disease for which the action is being taken

• The name and address of the owner-claimant, the name of all partners if joint ownership, and the location of the premises where the appraisal is made

• The number, species, age, sex, breed, and identification of each animal appraised

• The appraisal value per unit, unit type, and weight or number of units appraised

• The total appraisal value of grade and purebred animals or materials appraised

• Amount due from either or both Federal and State agencies, once adjusted for salvage value

Justification for Brucellosis Herd Depopulation (VS 4-6)

This form is used to obtain approval for the destruction of infected herds. It is prepared as needed by the DBE, approved by the AVIC, and submitted to the regional brucellosis epidemiologist and the brucellosis program manager. It is also used by the AVIC in preparing the VS 1-23.

Agreement for Complete Herd Depopulation – Brucellosis (VS 4-7)

This form is prepared as needed by the DBE, approved by the AVIC, and submitted to the regional brucellosis epidemiologist and then to the brucellosis program manager. It is also used by the AVIC in preparing the VS 1-23. The form lists the name and address of the herd owner, the species and number of animals in the herd, the number of exposed nonreactors to be destroyed, and a description of the nonreactor animals.

Certificate of Veterinary Inspection (CVI)

This form is prepared as needed by an accredited veterinarian to document interstate movement of animals. The certificate contains: (1) the number and description of animals to be moved, (2) a statement that the animals are not showing signs of infectious, contagious, or communicable diseases, (3) the purpose for which the animals are to be moved, (4) the shipment's points of origin and destination, and (5) the names and addresses of the consignor and consignee. The document is used in brucellosis epidemiological investigations if brucellosis is detected in an animal or herd.

Quarantine and Quarantine Release Forms

These forms are prepared as needed by State animal health officials to document the quarantine of brucellosis affected animals or herds and release from quarantine of animals or herds. The form documents that the appropriate procedures have been used to prevent transmission of brucellosis to other animals or herds.

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.

Automated and electronic information technology is available and used by States to submit their annual and monthly reports (VS Form 4-1 and VS Form 4-1D). The VS Center for Epidemiology and Animal Health (CEAH) developed and implemented the AWBDS in 2004. The AWBDS allows States to enter data directly into the program’s disease database via Web access, reducing the burden of accessing data. Data may be entered by personnel at the VS Area office or the State’s animal health agency. VS program staff no longer need to download the data submission files and merge the data into the database, a process necessary to access data with the Generic Database.

VS adopted the AWBDS to improve efficiency in the data collection process and to provide a means for data quality assurance. The AWBDS allows for real-time data collection and eliminates a cumbersome multistep data entry process. Automated annual reports summarize the monthly data submitted. The use of automated annual reports allows for direct access, summarizing, and reporting of the data in the AWBDS, with reports generated in their appropriate format.

The AWBDS is an internal program database maintained by CEAH. Access to this database is limited; approved users have a user ID and passcode. The Oracle Application Server Web address is http://ahsm2.aphis.usda.gov/forms/frmservlet?config=ahsm

CEAH continues to refine the AWBDS by developing a more comprehensive Animal Health Surveillance Management (AHSM) system to allow for the sharing of animal identification, animal movement, and animal health management activities across all disease programs. The intent is to significantly increase the efficiency and effectiveness of data collection and data management. These efforts have evolved to include the development of the Surveillance Collaboration Services (SCS) database. This system stores data from several existing databases, including the AWBDS and AHSM, and will serve as the repository for future VS data. SCS is being made available to interested States.

APHIS or State personnel enter information provided by producers and nonproducer entities (livestock markets, slaughter plants, and dealers) into the AWBDS or SCS. Information is from the various official forms and other listed activities and includes owner name, address, contact information, premises identification numbers, premises name, address, type of premises (production unit, market, slaughter plant, etc.), and species. Specific forms from which information is collected and currently being entered into the AWBDS or SCS are the VS Forms 4-24, 4-26, 4-34 and 4-33A, and 4-54.

CEAH has developed an electronic VS 4-33 form (Brucellosis Test Record) and an electronic

VS 4-24 form (Calfhood Vaccination Record) which are used in the Mobile Information Management (MIM) system. Information collected via the MIM system can also be uploaded into the SCS. These electronic forms are in use in the field and incorporate use of electronic animal identification information being applied and read onsite to populate the appropriate information collection fields on these forms. Use of these automated forms significantly decreases the time and collection burden on producers, private veterinary practitioners, and State and Federal animal health officials, all of whom are the primary parties involved in the preponderance of information collection.

An electronic version of the VS 4-54 form (Brucellosis Test Record Market Cattle Testing Program) is under development. This form is used regularly for market cattle and market swine surveillance sample collections. APHIS anticipates that its integration with national animal disease traceability devices (electronic animal identification) and AWBDS, AHSM, and SCS will significantly facilitate program-required monthly and annual reports.

All other forms described in this collection are not used often enough to warrant automation at this time. The CVI form and Quarantine and Quarantine Release forms are State-issued forms.

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.

The information that APHIS collects in connection with this program is not available from any other source. APHIS is the only Federal agency responsible for preventing, detecting, controlling, and eliminating bovine brucellosis and other domestic diseases of animals and poultry from the United States.

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

The information collected is the absolute minimum needed to conduct effective brucellosis surveillance, control, and eradication efforts. The on-farm testing and vaccinating of livestock and the issuing of interstate health certificates commonly occurs on commercial farms and small livestock producer (dairy, beef, cow-calf, and swine) operations, and includes activities conducted by private licensed accredited veterinarians, all of which are considered small entities. The few suspect and reactor animal epidemiological investigations and affected herd epidemiological investigations conducted each year may involve either commercial farms or small livestock producers considered to be small entities. Therefore, APHIS estimates that 100 percent of the respondents in this collection are 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.

If the information were conducted less frequently or not at all, APHIS would not be able to conduct an effective bovine brucellosis surveillance and eradication program. Consequently, bovine brucellosis would likely spread to areas of the United States that are currently classified free of the disease. This would have a potentially devastating effect on U.S. livestock markets and trade.

7. 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;

VS 4-33D - Monthly Report of Brucellosis Program Activities: This form is reported monthly.

VS 4-52 – Report of Back Tags Applied: The form is submitted on a daily to monthly basis depending upon the number of back tags applied.

VS 4-54 – Brucellosis Test Record Market Cattle Testing Program: The form is prepared on a daily basis at the slaughter facilities and whenever it is required at the livestock markets.

VS 4-54D – Monthly Report of Brucellosis Program Surveillance Activities: This form is reported monthly.

APHIS requires reporting and collection of information at frequent intervals to ensure that program activities are being carried out as regulations require. Moreover, frequent testing and rapid review of results allows APHIS and States to respond promptly and appropriately to the brucellosis situation in the State or Area.

• 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 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.

8. 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.

In 2012, APHIS engaged in productive consultations with the following stakeholder organizations concerning the information collection activities associated with this program:

Dave Carter

National Bison Association

8690 Wolff Ct. #200

Westminister, CO 80031

(303) 845-9081

Mallory Gaines

National Cattlemen’s Beef Association

1301 Pennsylvania Ave. NW

Suite 300

Washington, D.C. 20004

(202) 347-0228

Dana Brooks

National Milk Producers Federation

2101 Wilson Blvd, Suite 400

Arlington, VA 22201

(703) 243-6111

On Wednesday, July 18, 2012, pages 42256 - 42257, APHIS published in the Federal Register, a 60-day notice seeking public comments on APHIS’ plans to request a 3-year extension of this collection of information. During that time APHIS received two comments. The first comment, from Lucas Wynne, supported the Brucellosis Program and provided some background information on the disease. The second commenter expressed her feelings about the taxpayers covering the cost of the Brucellosis Program. Neither comment had relevance to the purpose of the collection.

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

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

10. 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. Any and all information obtained in this collection shall not be disclosed except in accordance with

5 U.S.C. 552a.

11. 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.

12. 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 based on real-time use and discussions with commercial livestock farm owners and managers; animal agriculture-related business owners and managers; private veterinarians; animal agriculture-related agencies and organizations; breed registry agencies; agriculture extension agents; fair and exhibition officials; owners, operators, and managers of livestock markets; owners, operators, and managers of slaughter establishments and dairy plants; and State animal health officials and laboratory personnel.

•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 annualized cost to these respondents to be $6,391,544.23. APHIS arrived at this figure by multiplying the hours of estimated response time (252,331 hours) by the estimated average hourly wage of the above respondents ($25.33). APHIS derived the estimated wage by averaging the following figures from the U.S. Department of Labor; Bureau of Labor Statistics May 2011 Report - Occupational Employment and Wages in the United States.] See http://www.bls.gov/news.release/pdf/ocwage.pdfhttp://www.bls.gov/news.release/pdf/ocwage.pdf

Farmers, ranchers, and other agricultural managers: $33.66

Animal scientists: $32.44

Agricultural technicians $17.38

Veterinarians $43.87

Animal breeders $18.11

Ranch farmworkers $11.60

Inspectors $20.25

13. Provide estimates of the total annual cost burden to respondents or recordkeepers 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.

14. 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 $4,935,983.04. (See APHIS

Form 79.)

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

ICR Summary of Burden:

	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	987,153	0	-190,068	0	0	1,177,221
Annual Time Burden (Hr)	252,331	0	-188,253	0	0	440,584
Annual Cost Burden ($)	0	0	0	0	0	0

There is a program change decrease of -27,982 respondents and -190,068 annual responses resulting in a decrease of -188,253 burden hours. This information collection continues to include all VS forms used by the brucellosis program since its inception.

• The decreases for this collection are because the program is moving from eradication to surveillance. This shift in program activities most significantly affects testing, as described below:

1. As of July 2009, all 50 States were officially classified Class Free for bovine brucellosis, relieving requirements for testing for interstate movement of animals.

2. The changes made to the program by the brucellosis interim rule published in the Federal Register December 27, 2010 reduced the amount of testing required to maintain Class Free status for States that have been Class free for 5 or more years and have no Brucella abortus in wildlife. These changes included eliminating BRT surveillance testing, removing the provision for automatic reclassification of any Class Free State if two or more herds are found to have brucellosis within a 2-year period or if a single brucellosis-affected herd is not depopulated within 60 days, and providing an alternative testing protocol for maintaining certified brucellosis-free status for dairy herds. The changes gave producers more flexibility for the herd certification process.

APHIS has also consolidated testing of bovine brucellosis slaughter surveillance samples to nine regional laboratories, maximizing efficiency and minimizing sample shipping and testing costs. Further, APHIS has transitioned to the new national bovine brucellosis slaughter surveillance plan which decreased bovine slaughter surveillance testing by approximately 50 percent while still providing the highest probability of detecting brucellosis and maintaining geographical representation of our national cattle herd.

16. 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.

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.

APHIS has no plans to seek approval for not displaying the OMB expiration date on the forms listed below:

VS 4-1 – Application for Brucellosis Classification or Reclassification of State

VS 4-1D – Application for Validation of a Brucellosis Free Area

VS 4-6 – Telecopy Justification for Brucellosis Herd Depopulation

VS 4-7 – Agreement for Complete Herd Depopulation–Brucellosis

VS 4-13 – Certified Herd – Cooperative Brucellosis Eradication:

VS 4-33 – Brucellosis Test Record

VS 4-33A – Brucellosis Test Record – Continuation Sheet

VS 4-33D – Monthly Report of Brucellosis Program Activities

VS 4-38 – Brucellosis Ring Test Rack Chart

VS 4-39 – Brucellosis Ring Test Patron List

VS 4-39A – Patron Listing, Cooperating

VS 4-34 – Cooperative/State Federal Brucellosis Test Record

VS 4-52 – Report of Back Tags Applied

VS 4-52A – Report of Back Tags Applied – Continuation Sheet

VS 4-54 – Brucellosis Test Record Market Cattle Testing Program

VS 4-54D – Monthly Report of Brucellosis Program Surveillance Activities

VS 4-59 – Quarterly Report of Brucellosis Program Surveillance Activities

VS 4-80 – Application for Validated Brucellosis Free Herd Certificate

VS 4-100 – Log for Market Cattle Test Reactors

VS 4-106 – Field Investigation of Brucellosis Market Test Reactors

APHIS is seeking approval to not display the OMB expiration date on the forms listed below because these forms are serially numbered to track the movement of the shipment for regulatory purposes. Also they are composed of multiple parts using carbon to provide copies. It is not practical to store these forms for long periods of time because the carbon breaks down in storage.

VS 4-24 – Calfhood Vaccination Record (short form)

VS 4-26 – Calfhood Vaccination Record (long form)

VS 4-108 – Epidemiological Investigation of Brucellosis Reactor Herd

VS 4-108A – Origin of Reactor/Herd Additions

VS 4-108B – Animals Removed from Infected Herd

APHIS is seeking approval to not display the OMB expiration date on the forms listed below because these forms are used in a number of collections; therefore, it is not practical to include an OMB expiration date because of the various expiration dates for each collection.

VS 1-23 – Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed – 0579-0007, 0579-0047, 0570-0101, 0579-0137, 0579-0189, 0579-0189 and 0579-0192

VS 1-23A – Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed Continuation Sheet - 0579-0007, 0579-0047, and 0579-0101

VS 1-27 – Permits for Movement of Restricted Animals – 0579-0047, 0579-0101, 0579-0127, 0579-0185, and 0579-0338.

18. Explain each exception to the certification Statement in the "Certification for Paperwork Reduction Act."

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

There are no statistical methods associated with the information collection activities used in this program.