0299 2022 Ss (20221006)

October 2022

SUPPORTING STATEMENT

National Animal Health Reporting System (NAHRS)

OMB CONTROL NO. 0579-0299

NOTE: This request for renewal includes the merger of ICR 0579-0476. Upon approval of the request, 0579-0476 will be discontinued.

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, to include SARS-CoV-2. 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, of the Farm Security and Rural Investment Act of 2002.

Disease prevention is the most effective method for maintaining a healthy animal population and enhancing the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), Veterinary Services’ (VS) ability to allow U.S. animal producers to compete in the world market of animal and animal product trade.

In connection with this mission, the Animal and Plant Health Inspection Service (APHIS) operates the National Animal Health Reporting System (NAHRS), which collects, on a national basis, data on the prevalence of important livestock and poultry diseases within the United States.

The NAHRS collects data monthly from State veterinarians on the presence or absence of specific diseases of interest to the World Organization for Animal Health (Office International des Epizooties) (OIE). As a member country of the OIE, the United States is required to submit reports on the status of certain diseases notifiable to the OIE. Reportable diseases are diseases that have the potential for rapid spread, irrespective of national borders, that are of serious socio-economic or public health consequence and that are of major importance in the international trade of animals and animal products. The potential benefits to trade as a result of the NAHRS include accurate reporting on the health status of the U.S. livestock industry, improved and expanded animal disease reporting infrastructure, expansion of livestock industries into new export markets, and preservation of existing markets through increased confidence in quality and disease freedom of U.S. livestock. This data collection is unique in terms of the type, quantity, and frequency of data; no other entity is collecting and reporting this type of data on the health status of U.S. livestock to the OIE.

APHIS is asking the Office of Management and Budget (OMB) to approve, for 3 years, its use of this information collection.

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.

NLRAD NAHRS Monthly State Report Form (NAHRS 1 or VS 12-10); (9 CFR 1-199); (State, Local, and Tribal) Government)

The NAHRS 1 monthly state report form was formerly referred to as VS Form 12-10.

On a monthly basis, each State animal health official (State Veterinarian) completes and submits this report to APHIS. The form collects primarily qualitative data (i.e., yes / no responses on disease presence) from States on the confirmed presence or absence of diseases which are based on test results and confirmed observational data. A “yes” response from the State indicates that at least one new case of disease was confirmed during a specific month. A “no” response indicates that no new confirmed cases of the disease were confirmed in the State during the specific month.

The form is divided into 11 sections: Bovine, Cervids, Caprine and Ovine, Equine, Porcine, Avian, Lagomorph (Rabbits and Hares), Other Diseases, Bee (optional reporting), Aquaculture, and Amphibian diseases. At the top of the form there is a space to indicate the State of origin and the current month and year. Under each section are rows of OIE notifiable diseases that correspond to each of the species, a column for the respondent to indicate the presence or absence of each disease (“Yes” or “No”), and a space for comments. At the bottom of the form is a section for the collection of additional information for Equine Infectious Anemia (EIA) testing. There are five questions asking for State-wide counts of tests, horses tested, horses tested positive, number of positive premises, and total horses quarantined for EIA during that month. The State veterinarian may complete/return the form via the Internet, email, mail, or fax to USDA/APHIS/VS for analysis and inclusion in the semi-annual NAHRS report.

NLRAD Emerging Disease Reporting Form (NAHRS 2); (21 U.S.C. 119); (State, Local, and Tribal Government)

Merged from 0579-0476.

This form is used by the State Animal Health Official to report additional data related to laboratory testing results for SARS-CoV-2 submissions originating from his/her State. Most data provided to the State Animal Health Official is epidemiological information further clarifying the circumstances for submission of SARS-CoV-2 test samples.

The form asks a series of 13 questions: eight questions have yes-no-unknown answer options; five questions offer other prescribed answer options; and two questions request a brief free-form answer response. There is a header at the top of the form indicating the animal identified by a submitted sample, the laboratory where the SARS-CoV-2 testing occurred and the sample submission details (State where the sample was collected and dates of sample collection, receipt at the lab, and testing). This header information assists the State Animal Health Official in correctly reporting any additional epidemiological data specific to the described SARS-CoV-2 sample and testing. The State Animal Health Official completes one form concerning each animal tested for SARS-CoV-2 from his/her State. The form/s are submitted online in conjunction with monthly NAHRS disease reporting by the State Animal Health Official.

SARS CoV-2 Testing Data from Testing Laboratories (NVSL 201); (21 U.S.C. 119); (Private)

Merged from 0579-0476.

NVSL 201 is an Excel workbook recording the name of the testing lab, test purpose, lab accession number, species, barcode or specimen ID, animal ID, specimen, submission reason, clinical signs, date collected, date specimen received, date tested, test type, PCR CT value, test result interpretation, premises state, submitter and owner information, and an option for comments. The form is delivered electronically to NVSL each month when positive tests deem it appropriate.

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.

NAHRS 1 and NAHRS 2 are available at https://www.aphis.usda.gov/aphis/ourfocus/

animalhealth/monitoring-and-surveillance/sa_disease_reporting/ct_info_for_participants). Forms may be completed/submitted electronically via the Internet, emailed to NLRAD.NAHRS@aphis.usda.gov, faxed, or mailed to USDA/APHIS/VS, Attn: NAHRS Coordinator, 2150 Centre Ave, Bldg. B, MS 2E6, Fort Collins, CO 80526. Web-based form completions are performed on a permissions-restricted, secure submission site, open only to approved data providers.

The NAHRS 2 was added directly to the NAHRS reporting system. Respondents are able to enter data at the same time they report other monthly disease trends in their States.

Submissions of the NVSL 201 Testing Data from Testing Laboratories is emailed electronically.

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 is not available from any other source. APHIS is the only Federal Agency responsible for monitoring and reporting the status of NLRAD or OIE notifiable diseases within the U.S.

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

APHIS estimates all of the private lab business respondents are small entities and collection of the information has no economic impact on them. The NVSL 201 has been designed to collect only the minimum amount of data required to understand the prevalence and spread of SARS-CoV-2 in animals, compile the OIE emerging disease reports, and meet other reporting duties.

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.

Monitoring the health status of U.S. commodities and submitting semi-annual reports to OIE is required for the United States to maintain OIE membership. The type, quantity, and frequency of data collected by the NAHRS is unique in the U.S., no other source/entity is collecting data of this nature or can be used to collect these data. Originally, this form was sent and completed on a quarterly basis, but respondents decided that monthly submissions would allow for data to be reported more accurately. Without this type of information collection activity, the U.S.’ ability to respond to international trade issues involving the health status of animal commodities could be severely reduced, jeopardizing the international marketability of meat and byproducts.

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, such as:

• 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;

On a monthly basis, each State animal health official (State Veterinarian) completes and submits the monthly NAHRS 1 report to APHIS.

• 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 3 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 record keeping, 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 publications in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB.

APHIS engaged in productive consultations with the individuals below concerning the information collection activities associated with the NAHRS. Discussed were the importance of gathering NAHRS data, the usefulness of having an electronic means for State animal health officials to submit their reports, and continued support for NAHRS. They were supportive of these efforts and had no recommendations for improving the collection of information in this request.

John Easley, DVM

Director of Research and Farm Services Veterinarian

Fur Commission USA

Email johneasleydvm@hotmail.com

Tel. 920-980-9660

Maggie Baldwin, DVM

State Veterinarian

Colorado Department of Agriculture

Tel. 303-869-9132

Dean Taylor, DVM

State Veterinarian

Utah Department of Agriculture

Email djtaylor@utah.gov

Tel. 801-982-2243

On June 7, 2022, APHIS published, in the Federal Register a 60-day notice seeking public comments on its plans to request renewal of this information collection. APHIS received one comment but it was not relative to the activities covered in this request.

9. Explain any decision to provide any payment of gift to respondents, other than renumeration 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.

There are no questions of a sensitive nature used in this collection activity.

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 for hour burden estimates.

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

The total annualized cost to respondents is $438,520 computed by multiplying the estimated average hourly wage ($45.75) by the total number of burden hours needed to complete the work (6,615), and then multiplying the product ($302,636) by 1.449 to capture benefit costs.

The average hourly rates used to calculate the estimate are for veterinarians (SOCC 29-1131, $52.84) and animal scientists (SOCC 19-1011, $38.65) using information found at the U.S. DOL Bureau of Labor Statistics occupational employment statistics website at http://www.bls.gov/current/oes_stru.htm.

According to DOL BLS news release USDL-22-0469 released March 18, 2022, employee benefits account for 31 percent of employee costs, and wages account for the remaining 69 percent. Mathematically, total costs can be calculated as a function of wages using a multiplier of 1.449.

13. Provide estimates 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 estimate should be split in to two components: (a) a total capital and startup cost component annualized over its excepted useful life; and (b) a total operation and maintenance and purchase of services component.

There is zero annual cost burden 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.

See APHIS 79. The annualized cost to the Federal government is estimated at $582,229.

15. Explain the reasons for any program changes or adjustment reported in Items 12 or 14 of the OMB Form 83-1.

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	1,548	0	0	924	0	624
Annual Time Burden (Hours)	6,615	0	0	1,623	0	4,992

There are no estimate adjustments to the previous 0579-0299 submission. However, this request for renewal includes the merger of 0579-0476 and two of its activities, NLRAD Emerging Disease Reporting Form and SARS CoV-2 Testing Data from Testing Laboratories. The two activities add 924 responses and 1,623 hours of burden. The third activity in 0579-0476, Request for Information for U.S. Laboratories, was discontinued.

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

Information from these forms will be tallied immediately following each monthly data collection to provide descriptive information regarding the presence of notifiable diseases as a report on the status of U.S. animal health. Results will appear in monthly and semi-annual OIE reports that indicate the presence of these diseases within the U.S. The results will also appear in trends reports and annual NAHRS reports, as described in question 2.

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 will display the expiration date.

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

APHIS certifies compliance with all provisions of the Act.