0409 Ss 20171012

0409 SS 20171012.docx

National Veterinary Services Laboratories; Bovine Spongiform Encephalopathy Surveillance Program

OMB: 0579-0409

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SUPPORTING STATEMENT - OMB NO. 0579-0409

NATIONAL VETERINARY SERVICES LABORATORIES; Bovine Spongiform Encephalopathy Surveillance Program


September 2017



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 globally in animal and animal product trade.


In connection with this mission, the USDA’s Animal and Plant Health Inspection Service (APHIS) National Veterinary Services Laboratories (NVSL) safeguard U.S. animal health and contribute to public health by ensuring that timely and accurate laboratory support is provided by their nationwide animal health diagnostic system.


The USDA complies with the standard set by the World Organization for Animal Health (OIE) for bovine spongiform encephalopathy (BSE) surveillance. This compliance is critical for maintaining our BSE risk status with the OIE. In 2013, the OIE granted the United States negligible risk status for BSE, improving our standing with trading partners and reducing our surveillance requirements. As a result, in Fiscal Year 2016 the target for BSE samples was reduced from 40,000 to 25,000 samples annually. Our BSE surveillance program requires several information collection activities, including completing VS Form 17-146, the BSE Surveillance Submission Form; VS Form 17-146a, the BSE Surveillance Submission Form Continuation Sheet; and VS Form 17-131, the BSE Surveillance Data Collection Form.


APHIS is asking the Office of Management and Budget (OMB) to approve its use of these information collection activities for 3 years in connection with APHIS’ efforts to ensure that NVSL can continue to effectively safeguard the U.S. animal health population against BSE.



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 following information collection activities to safeguard the U.S. animal health population against BSE.


VS Form 17-146 - BSE Surveillance Submission Form (Business) (State) (7 CFR 371.4, 9 CFR 130.49)

This form is used to submit diagnostic samples for BSE testing. The form captures contact information for the submitter; information regarding where, and by whom, the sample was collected; unique identifiers for each sample being submitted; and tracking/control numbers.


VS Form 17-146a - BSE Surveillance Submission Form Continuation Sheet (Business) (State) (7 CFR 371.4, 9 CFR 130.49)

This form is used to capture additional sample identifiers if the size of the submission exceeds the number of sample ID blanks on VS Form 17-146.


VS Form 17-131 - BSE Surveillance Data Collection Form (Business) (State) (7 CFR 371.4, 9 CFR 130.49)

This form is used only with VS Form 17-146 and 17-146a. A single VS Form 17-146 is completed for each submission to a diagnostic laboratory, but a single submission may contain samples from multiple animals. Epidemiological information about the animal from which each sample was obtained is critical for an effective surveillance program. Submitters are asked to complete a separate VS Form 17-131 for each animal in the submission described on VS Form 17-146. VS Form 17-131 captures the reason the animal was selected for surveillance; the owner’s contact information; slaughter site contact information; the animal’s breed, age, gender, and identifying numbers; descriptions of medical conditions the animal exhibited; and the animal’s country of origin.


The data for all three of the above forms is routinely provided by slaughter establishments, offsite collection facilities for condemned slaughter cattle, rendering 3D/4D facilities, and accredited veterinarians. The information may also be provided by State animal health personnel or veterinary diagnostic laboratories. The forms are submitted to APHIS (i.e., NVSL) or a contract laboratory (i.e., State or University veterinary diagnostic laboratory that is part of the National Animal Health Laboratory Network (NAHLN)).



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 data captured on these forms may be entered by authorized respondents directly into a Web-based database administered by APHIS for the NAHLN. The physical forms are used by those who do not want to enter the data directly into the database or do not have access to do so. The forms will be available online in fillable PDF format so that they may be completed electronically and printed. Paper copies of the forms (or form-equivalent reports from the database) are included in the physical shipment of samples to the diagnostic testing laboratories.


Fillable PDF versions of the forms can be found

http://www.aphis.usda.gov/library/forms/index.shtml


Database (secure)

https://vsapps.aphis.usda.gov/vslabsub/login.do



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 APHIS collects in connection with this effort is not available from any other source. APHIS is the only Agency responsible for safeguarding U.S. livestock against the incursion of BSE.



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


Approximately 90 percent of the respondents in this collection are small businesses. APHIS has attempted to reduce the burden to small businesses by providing electronic versions of the forms. Small businesses may complete these electronic forms with fixed information for their businesses and save the partially filled forms as a template. Then only the information that changes with each new submission must be completed.



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 monitor and prevent the incursion of BSE into the United States. We would also be unable to validate the surveillance necessary to maintain our negligible risk status for BSE with the OIE. This would cause serious health consequences to U.S. livestock and economic consequences for the U.S. livestock industry, which would be unable to export live animals or animal products due to trade restrictions.



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;

  • requiring respondents to submit more than an original and two copies of any docu­ment;

  • requiring respondents to retain re­cords, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

  • in connection with a statisti­cal sur­vey, that is not de­signed to produce valid and reli­able results that can be general­ized to the uni­verse of study;

  • requiring the use of a statis­tical data classi­fication that has not been re­vie­wed and approved by OMB;

  • that includes a pledge of confiden­tiali­ty that is not supported by au­thority estab­lished in statute or regu­la­tion, that is not sup­ported by dis­closure and data security policies that are consistent with the pledge, or which unneces­sarily impedes shar­ing of data with other agencies for com­patible confiden­tial use; or

  • requiring respondents to submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permit­ted by law.


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



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.


APHIS spoke to the following individuals concerning the information collection activities associated with this program:


Eileen Danielson

County Services, Inc

PO Box 1698

Plainview, TX 79073

(806) 293-4431  


Wendy Peterson

Riverview LLC

76 North 400 West

Burley, ID 83318

(208) 678-9501


Barb Bolt

Southern Tier Hide & Tallow, Inc

3385 Lower Maple Ave

Elmira, NY 14904

1-800-333-1460 ext 221


On Monday, January 23, 2017, pages 7788-7789, APHIS published in the Federal Register a 60-day notice seeking public comments on its plan to request a 3-year renewal of this collection of information. No comments from the public were received.



9. 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 other than remuneration to contractors.



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 from discussions with NVSL employees and contract laboratories.


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


Respondents are slaughter establishments, offsite collection facilities for condemned slaughter cattle, rendering 3D/4D facilities, or accredited veterinarians. The information may also be provided by State animal health personnel or veterinary diagnostic laboratories. APHIS estimates the total annualized cost to these respondents to be $95,559.66. APHIS arrived at this figure by multiplying the hours of estimated response time (3,026 hours) by the estimated average hourly wage of the above respondents ($31.91).


The hourly rate was derived from the U.S. Department of Labor, Bureau of Labor Statistics May 2016 Report - Occupational Employment and Wages in the United States. See http://www.bls.gov/oes/current/oes_nat.htm.



13. 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.



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 $102,155. (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-I.



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

30,248

0

30,248

0

0

0

Annual Time Burden (Hr)

3,026

0

3,026

0

0

0


This is a violation of a previously approved information collection resulting in a program change of 30,248 annual responses and 3,026 annual burden hours.



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.


Not applicable. APHIS will display the 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 under the Act.



B. Collections of Information Employing Statistical Methods


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


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