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9 CFR 75 Communicable Diseases in Horses

OMB: 0579-0127

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SUPPORTING STATEMENT – OMB NO. 0579-0127

COMMUNICABLE DISEASES IN HORSES

July 2013

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 is the most effective method for maintaining a healthy animal population and for enhancing our ability to compete in the world market of animal and animal product trade.


Veterinary Services (VS), a program within USDA's Animal and Plant Health Inspection Service (APHIS), is responsible for administering regulations intended to ensure that horses affected with equine infectious anemia (EIA) are moved interstate in a way that does not endanger the health of the U.S. equine population. APHIS regulations at title 9, Code of Federal Regulations (9 CFR) 75.4 deal specifically with regulating the interstate movement of horses affected with equine infectious anemia (EIA).


Ensuring the safe movement of these horses requires VS to engage in a number of information collection activities such as 1) guiding animal owners in obtaining and completing a Permit for the Movement of Restricted Animals (VS Form 1-27), 2) guiding animal owners in obtaining and documenting a laboratory test for EIA using VS Form 10-11, the Equine Infectious Anemia Laboratory Test, 3) conducting and documenting an investigation of the farm of origin for any horse that returns a positive result for an EIA test using VS Form 10-12, the, Equine Infectious Anemia Supplemental Investigation; and 4) having facilities that conduct EIA-related activities sign a cooperative agreement promising adherence to APHIS regulations. Diagnostic and research laboratories must also notify VS in writing when they no longer accept EIA reactors moved interstate. Finally, any stockyard, diagnostic facility, or other facility that loses VS approval may request a hearing regarding the decision, but must do so in writing.


APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities in connection with its program to prevent the spread of EIA within the U.S. equine population.

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.


Permit for the Movement of Restricted Animals (VS Form 1-27)


At the time animals are loaded and ready for transport, Federal officials use information obtained from the animal owner to complete the VS Form 1-27. The information obtained from the owner and entered on the form includes the owner’s name and address, the points of origin and destination of the animals, the number of animals being moved, the purpose of the movement, and various pieces of animal identification data, such as a microchip number or a physical description, so that each animal in the shipment can be identified. This form accompanies the shipment and is submitted to VS after the animals reach their destination.


Equine Infectious Anemia Laboratory Test (VS Form 10-11)


This form is completed by a Federal official who has been called to a farm to conduct an EIA test on a horse. The horse's owner − who provides the information the official needs to complete the form – may have several reasons for wanting the horse tested, but a primary reason would be that the owner wants to move the horse across State lines. The official takes a blood sample from the horse and then sends this sample (along with VS Form 10-11) to a VS-approved laboratory for analysis. The VS Form 10-11 provides a physical description of the horse, the date the sample was taken, the owner's name and address, and the name of the official who took the sample. The laboratory personnel need the information on VS Form 10-11 to link the blood sample to the horse from which the sample was drawn. Laboratory personnel complete the lower half of the form after obtaining test results and send the form to VS.


Equine Infectious Anemia Supplemental Investigation (VS Form 10-12)


If a horse’s blood sample is positive for EIA, then the farm where the horse resides must undergo a full investigation. Federal officials complete this form using information provided by the animal owners during the investigation. The VS Form 10-12 contains such information as the vaccination history of the horses on the farm, the number of horses with which the positive horse shares a pasture, and a site sketch of the farm. Receiving this vital information allows VS to effectively coordinate an EIA investigation and make critical decisions concerning which areas to quarantine.


Agreement for Approved Livestock Facility (Signature Only)


The owner or operator of a participating stockyard, laboratory, or diagnostic or research facility must promise to adhere to VS’ guidelines and regulations when carrying out EIA-related activities. These requirements are spelled out in a cooperative agreement that the owner or operator must sign and return to VS.



Request for Hearing


If VS opts to deny or withdraw approval from a stockyard, laboratory, or diagnostic or research facility, the owner or operator of that facility may appeal the denial or withdrawal in writing within 10 days after receiving notification. The appeal must include all of the facts and reasons on which the owner or operator relies to show that the establishment was wrongfully denied listing. The owner or operator of that establishment may also request a hearing on the matter. During the hearing, the owner or operator may present arguments in support of continuing approval. The request for this hearing must be made in writing by the owner or operator and sent directly to VS.


Written Notification of Approval Withdrawal


APHIS will automatically withdraw approval for a diagnostic or research facility to receive EIA reactors moved interstate when the facility’s operator notifies APHIS, in writing, that the facility no longer receives reactors moved interstate.



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.


The VS Form 1-27 must physically accompany the shipment of animals from the farm of origin to the slaughtering establishment. To be valid, the form requires original signatures from owners and VS personnel at both the farm of origin and the slaughtering establishment. The form is therefore not a candidate for electronic submission.


VS Form 10-11 must physically accompany samples sent to the laboratory for analysis, and is therefore not a candidate for electronic submission.


VS Form 10-12 must include a sketch of the affected premises, and is therefore not a candidate for electronic transmission.


Agreements require original signatures by all signing parties to be valid and are therefore not candidates for electronic submission.


The request for hearing and Written Notification of Approval Withdrawal may be made via a telephone call or email to APHIS. For legal purposes, however, electronic communication must be followed up in writing containing original signatures.



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 for the EIA program is exclusive to its mission of regulating the interstate movement of horses to prevent the spread of disease, and is not available from any other source.



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


The information APHIS collects is the minimum needed to ensure that horses moving interstate do not pose a health threat to the U.S. equine population. More than 90 percent of all respondents in the collection are considered 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 was collected less frequently or not collected, APHIS would be unable to establish an effective defense against the spread of EIA. This could have serious health consequences for U.S. equines and economic consequences for the U.S. equine industry.



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;

  • requiring respondents to prepare a writ­ten response to a collection of infor­ma­tion in fewer than 30 days after receipt of it;

  • 1. If APHIS denies the listing of an establishment, the owner or operator of that facility may appeal the denial in writing within 10 days after receiving notification.


  • 2. If APHIS withdraws approval from a facility, the owner or operator of that facility may appeal the withdrawal in writing within 10 days after receiving notification.



  • 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.


On Tuesday, September 24, 2013, pages 58513-58514, 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. No comments from the public were received.


In 2013, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:


Mike Erskine, DVM, DABVP-Equine

Damascus Equine Associates

1941 Long Corner Road

Mount Airy, MD 21771


Jennifer LaPlume, DVM

Ragged Mountain Equine Services

4112 Red Hill School Rd.

North Garden, VA 22959





W. Kent Fowler, DVM

Animal Health Branch Chief

California Department of Food and Agriculture

1220 N Street, A-110 (mailing address)

Sacramento, CA 95814



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. However, the confidentiality of information is protected under 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 from discussions with accredited veterinarians who participate in APHIS’ program; laboratory, diagnostic, and research facility personnel; and owners and shippers of horses.


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 the above respondents to be $4,492,018. APHIS arrived at this figure by multiplying the hours of estimated response time (139,547 hours) by the estimated average hourly wage of the above respondents ($32.19).

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


Veterinarians: $44.83

Owners and shippers [Farmers, ranchers, and other agricultural managers]: $35.45

Laboratory, diagnostic, and research facility personnel [Animal scientists]: $30.99/$17.49



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 $4,005. (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.

Annual IC Burden: (Select appropriate IC Burden Worksheet)

This ICR Requests Change in Net Burden

This ICR Requests No Change in Net 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 for this IC

1681142

0

0

-290101

0

1971243

Annual IC Time Burden (Hours)

139547

0

0

-24402

0

163949

Annual IC Cost Burden (Dollars)

0

0

0

0

0

0

In 2010, VS over calculated the anticipated number of respondents and responses which caused a decrease in the burden hours.


The VS 1-27 form was new to this collection at the last submission. The number of respondents (100) and responses (200) decreased to (3) respondents and (3) responses, the burden hours also decreased due to change in the per hours response time from .083 to .33.


The VS 10-11 numbers of respondents increased from 10,000 to 253,781, and the number of responses per hour decrease from 197 to 6, resulting in the decrease of number of responses from 1,970,000 to 1,681,118. Resulting in the total burden hours decrease from 163,510 to 139,533 hours. These adjusted figures represent actual use of this form to ship EIA-positive horses. In 2010 the program underestimated the use of the forms, but the current figures were actually gathered from actual reports.


The VS 10-12 numbers of respondents decreased from 200 to 3, and the decrease of number of responses from 1,000 to 15. Resulting in the total burden hours decrease from 416 to 11 hours. These adjusted figures represent actual use of this form to make critical investigation decisions concerning EIA-positive horses.


Finally, the decreased numbers for use of the Agreement for Approved Livestock Facility, Request for Hearing, and Written Notification of Approval Withdrawal reflect both more accurate accounting of actual use and decreased use owing to fewer requests for these processes from 42 to 6 respondents and 42 to 6 responses.


The total burden hours in 2011 totaled 163,949, and currently there is a decreased in burden hours 139,547. There was an adjustment of -24,402 total burden hours for this renewal due to the decrease of annual responses and refinements in VS’ calculations regarding numbers of respondents and the numbers of responses.



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.


VS Form 1-27 is used in multiple collections; therefore, it is not practical to include an OMB expiration date because of the various expiration dates for each collection. APHIS is seeking approval to not display the OMB expiration date on this form.


VS Forms 10-11 and 10-12 are serially numbered to track the movement of the shipment for regulatory purposes; therefore, APHIS is seeking approval to not display the OMB expiration date.



18. 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.



B. Collections of Information Employing Statistical Methods


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






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