0430 2024 - Supporting Statement A - 20241024

0430 2024 - Supporting Statement A - 20241024.docx

National Veterinary Services Laboratories Request Forms

OMB: 0579-0430

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Supporting Statement – Part A

OMB Control Number: 0579-0430

Title: National Veterinary Services Laboratories Request Forms

Date Prepared: October 2024



  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.


This is a request for extension, without change, of a currently approved information collection request. APHIS is asking the Office of Management and Budget (OMB) to approve for an additional 3 years, its use of these information collection activities in connection with the National Veterinary Services Laboratories Request Forms.


The Animal Health Protection Act (7 U.S.C. 8301-8317) provides the Secretary of Agriculture broad authority to prohibit or restrict, through orders and regulations, the importation or entry of any animal, article, or means of conveyance if USDA determines that the prohibition or restriction is necessary to prevent the introduction or spread of any pest or disease of livestock within the United States. Disease prevention is the most effective method for maintaining a healthy animal population.


As an element of the Animal and Plant Health Inspection Service (APHIS) disease prevention mission, the National Veterinary Services Laboratories (NVSL) safeguard U.S. animal health by providing timely and accurate laboratory support through a nationwide animal health diagnostic system. The NVSL’s work requires completing several information collection activities including the VS Form 4-9 (Request for Reagents or Supplies); VS Form 4-10 (NVSL Contact Information Update); VS Form 4-11 (NVSL Application for Laboratory Training); and VS Form 4-12 (NVSL Laboratories Kit and Instrument Order Form).



  1. Indicate how, by whom, 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 effectively safeguard the U.S. animal population from pests and diseases:


Request for Reagents or Supplies (VS Form 4-9); (9 CFR part 130); (Foreign Government; State, Local, or Tribal Government; Business)

Diagnostic laboratories (Federal, State, university, or private) or researchers (academia, private, or government), both domestic and foreign, must complete a VS Form 4-9 to request reagents or supplies from the NVSL. This form is used to ensure that the NVSL collects all the information needed to process the requests efficiently and accurately. The form is used every time a customer requests reagents or supplies (typically four times per year for an average customer).


NVSL Customer Contact Update (VS Form 4-10); (9 CFR part 130); (Foreign Government; State, Local, or Tribal Government; Business; Non-Profit; Individual)

Established diagnostic submitters, diagnostic laboratories (Federal, State, university, or for-profit businesses) or researchers (academia, private, government, nonprofit business), both domestic and foreign, can provide updated contact information. This form is not required but is offered as a courtesy to customers who wish to proactively inform the NVSL of changes in contact information. The form helps ensure that the NVSL obtains all necessary information to update records efficiently and accurately.


Request for Training at the NVSL (VS Form 4-11); (9 CFR part 130); (Foreign Government; State, Local, or Tribal Government; Business)

Laboratory personnel (Federal, State, university, private, foreign, or domestic) who wish to take an NVSL class must contact the NVSL training department directly via this form. This form helps ensure that the NVSL gets the information it needs to process training requests efficiently and accurately. The NVSL needs the information to know which courses the public wishes to take and to document that they have approval from the Area Veterinarian in Charge (when required).


NVSL Laboratories Kit and Instrument Order Form (VS Form 4-12); (9 CFR part 130); (Business; State)

Laboratory personnel use this form to order test kits and testing/sampling equipment from the NVSL. The sender provides their name (as the contact), the name of the requesting organization, the requesting organization’s address and telephone number, and the date of the request. Requesting contacts can fax or email the form to the NVSL Shipping Department.



  1. Describe use of technological collection technique. 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.


APHIS makes every effort to comply with E-Government Act, 2002 (E-Gov) and to provide for alternative submission of information collections.


The forms VS 4-9, VS 4-10, VS 4-11, and VS 4-12 may be downloaded from the APHIS Electronic Forms Library, and be submitted email, fax, or U.S. mail. Information from the VS 4-10 and VS 4-11 may also be transmitted via telephone. Web-based interfaces to submit these forms have been considered and may be implemented as resources and security considerations allow.


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


The information that APHIS collects is not available from any other source and every effort has been made to avoid duplication. These forms pertain to interactions specifically with the NVSL (reagent orders, NVSL-sponsored training). Contact information is configured according to customer preferences to receive communications and shipments specifically from the NVSL.



  1. Describe the impact to small businesses. If the collection of information impacts small businesses or other small entities (Item 5 of OMB Form 83-I), describe any methods used to minimize burden.


APHIS estimates that 70 percent of the business respondents are universities and small entities.



  1. Describe the consequences of not conducting information collection. What happens to the 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.


This is an ongoing voluntary information collection request. If the information is collected less frequently or not collected, APHIS will be unable to process reagent orders and provide requested training. The reagents, test kits, and testing supplies the NVSL distributes are critical for veterinary diagnostic testing and cannot be bought elsewhere. The training the NVSL provides is necessary to ensure that APHIS-approved laboratories are conducting diagnostic testing in the proper manner with proficient personnel, and in some circumstances cannot be conducted in alternative locations. Both service activities are critical to the NVSL mission as the USDA’s national reference laboratory.



  1. Explain any special circumstances that would cause an information collection to be conducted in a manner:

  • 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.



  1. Federal Register notice and consultation. 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 format (if any), and on the data elements to be recorded, disclosed, or reported.


APHIS consulted with the three individuals listed below (outside the agency) for this information collection request to obtain their views on the activities. The consultation with these individual stakeholders occurred by email and phone to discuss the information outlined in this package, i.e., the information APHIS collects to distribute reagents, forms, and other supplies, and track requests for laboratory testing, reagent use, and other lab-adjacent training. APHIS discussed the need for the data and frequency of collection; whether the forms were easy to use; and the clarity of, and necessity for, any recordkeeping requirements. The respondents stated they had no concerns with any of these activities and had no further recommendations.


Jennifer W.

Administrative Coordination Specialist

Texas A&M Veterinary Medical Diagnostic Laboratory (TVMDL)

979-845-3414


Lynn B.

Research and Information Specialist

Perdue Farms, Inc.

410-543-3269


Lester B.

Lab Technician

Murray State University

270-886-3959

On Monday, July 16, 2024, APHIS published in the Federal Register (89 FR 57843), a 60‑day notice seeking public comments on its plan to request a 3-year renewal of this collection of information. APHIS did not receive any comments from the public.



  1. 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.



  1. 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, Privacy Act of 1974.



  1. 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.



  1. 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.


  1. 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.


APHIS is seeking approval for 970 respondents, (affected public: 1 Individual/ Household; 768 Business; 109 State, Local, and Tribal; and 92 Foreign Government, etc.) 4,079 total annual responses and 1,013 total annual burden hours.

Burden estimates breakouts were developed from discussions with the animal scientists; life, physical and social science technicians; and veterinarians. See supporting APHIS Form 71.


  1. 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 $66,888. APHIS arrived at this figure by multiplying the number of estimated burden hours (1,013) hours) by the estimated average hourly wage of the below respondents ($46.22) and then multiplying the result ($46,821) by 1.4286 to capture benefit costs.


The average hourly rates used to calculate the estimates include the following:


Dept of Labor SOCC Code

Average Wage

Occupation Description

19-1011

$43.01

Animal Scientists

19-4099

$30.12

Life, Physical, and Social Science Technicians, All Other

29-1131

$65.53

Veterinarians


$46.22

Average Hourly Wage


APHIS derived the estimated wage by averaging the following figures from the U.S. Department of Labor; Bureau of Labor Statistics website.


According to DOL BLS news release USDL-24-0485 dated March 13, 2024, benefits account for 30 percent of employee costs, and wages account for the remaining 70 percent. Mathematically, total costs can be calculated as a function of wages, resulting in a multiplier of 1.4286.



  1. Capital and start-up and/or operation and maintenance. 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.



  1. 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.


See APHIS 79. The annualized cost to the Federal government is estimated at $198,106.




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


APHIS is seeking an extension of a currently approved information collection request. The currently approved burden for this request is 1,115 total annual respondents, 5,101 total annual responses and 1,223 total annual burden hours. This request for renewal is for 970 respondents, 4,079 estimated responses and 1,013 estimated burden hours. The requests reflects a decrease of 145 respondents, a decrease in 1,022 estimated responses and a decrease in 210 hours of estimated burden from the previous renewal request.


There are no third-party disclosure burden estimates.



Total Requested

Previously Approved

Change Due to New Statute

Change Due to Agency Discretion

Change due to Adjustment in Estimate

Change Due to Potential Violation of the PRA

Annual Number of Responses

4,079

5,101

0

0

(1,022)

0

Annual Time Burden (Hr)

1,013

1,223

0

0

(210)

0


Change(s) in estimate due to Agency discretion include:

  • There are no changes due to Agency discretion.


Change(s) in estimate due to adjustments in estimate are due to tracking revisions and increased accuracy in reporting, despite somewhat increased disease-related activity in the United States:

  • Requests for Reagents or Supplies (VS 4-9) estimates had a decrease in 145 respondents, 1,548 estimated responses and 386 estimated hours of burden. Estimates are attributed more likely due to laboratories being prepared and having the materials to conduct testing in stock.

  • Request for Training at NVSL (VS 4-11) estimates had a decrease of 11 respondents but an increase of 727 estimated responses and increase of 162 estimated hours of burden. Estimates are attributed to Novel disease situations and respondents being prepared for possible African swine fever incursions and an uptick in avian influenza.

  • NVSL Laboratories Kit and Instrument Order Form (VS 4-12) estimates had a decrease of 1 estimated response, 201 estimated responses, and 6 hours of estimated hours of burden. Estimates attributed to laboratories being prepared being prepared and having the materials in stock.


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


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


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


APHIS will display the OMB approval expiration date on the forms.



  1. 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


Statistical methods are not employed in this information collection activity

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AuthorKeegan, Regina - MRP-APHIS
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