Swine 2020 Part A 10162019

2019 SUPPORTING STATEMENT FOR INFORMATION COLLECTION

PART A

UNITED STATES DEPARTMENT OF AGRICULTURE (USDA)

ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

VETERINARY SERVICES (VS)

THE CENTERS FOR EPIDEMIOLOGY AND ANIMAL HEALTH (CEAH),

NATIONAL ANIMAL HEALTH MONITORING SYSTEM (NAHMS)

NAHMS SWINE 2020 STUDY

OMB NO. 0579-0315

A. Justification.

This submission is a request for approval to reinstate the National Animal Health Monitoring System’s (NAHMS) Swine 2020 Study, an information collection (0579-0315) by the Animal and Plant Health Inspection Service (APHIS). This study consists of a two phase, in person questionnaire based survey for large enterprise swine operations and a computer-assisted telephone interview (CATI) for small enterprise swine operations.

Large enterprise swine operations are those operations in 13¹ states that have 1,000 or more animals. This component of the study consists of two phases. In Phase I the National Agricultural Statistical Service (NASS) will perform an initial contact of 2,700 operations by telephone and personal interviews in order to collect operational level data and subordinate swine production site (locations where the animals are raised) contact information. NASS data collectors will perform a follow up contact with approximately 4,085 swine sites by telephone and personal interviews in order to collect site level data and respondent consent to be contacted for Phase II of the study. In Phase II, APHIS data collectors will contact consenting respondents to administer questionnaires and perform biologic sampling.

Small enterprise swine operations are those operations in 38² states who have fewer than 1,000 head. In this component of the study, NASS will mail questionnaires to producers, who will have the opportunity to self-administer the questionnaire and return it by mail. Those who do not respond will be followed up with via a computer-assisted telephone interview (CATI).

The collection will support the following objectives:

1. Describe current U.S. large scale swine production practices for gestation, farrowing, nursery, grower/finisher, and wean-to-finish phases, specifically as they relate to housing, productivity, biosecurity, and morbidity and mortality prevention,

2. Describe current U.S. small scale production practices including general management practices, housing practices, productivity, disease prevention, and mortality,

3. Determine the producer-reported prevalence of select respiratory, neurologic, gastrointestinal, systemic, and foodborne pathogens found in weaned market pigs,

4. Describe large scale swine production antimicrobial-use patterns in pigs from post-weaning to market age,

5. Evaluate the presence of select pathogens, and characterize isolated organisms from biological specimens (feces, oral fluids) in large scale swine production,

6. Describe trends in small scale swine health and disease management practices,

7. Describe trends in small scale swine production system movements, marketing and slaughter channels, and

8. Describe potential overlaps between small scale swine production system movements with those of larger total confinement/commercial operations.

Analysis of the information collected through the 2020 Swine Study will generate descriptive reports and information sheets. APHIS will disseminate and make available online these deliverables to producers, stakeholders, academia, veterinarians, and any other interested stakeholder. The benefits to the swine industry from the 2020 Swine Study include scientifically valid national estimates of health and management practices of the nation’s swine industry. The data collected will also be used to measure change over time from the previous NAHMS Swine studies for select parameters. Participation in this survey is voluntary. It is up to the individual producer to decide whether or not to participate.

1. EXPLAIN THE CIRCUMSTANCES THAT MAKE THE COLLECTION OF INFORMATION NECESSARY. IDENTIFY ANY LEGAL OR ADMINISTRATIVE REQUIREMENTS THAT NECESSITATE THE COLLECTION.

Collection and dissemination of animal health data and information is mandated by 7 U.S.C. § 391, the Animal Industry Act of 1884, which established the precursor of the APHIS, Veterinary Services, the Bureau of Animal Industry. Legal requirements for examining and reporting on animal disease control methods were further mandated by 7 U.S.C. § 8308 of the Animal Health Protection Act, “Detection, Control, and Eradication of Diseases and Pests,” May 13, 2002. This collection of swine data is consistent with the APHIS mission of protecting and improving American agriculture’s productivity and competitiveness.

In connection with this mission, the NAHMS program includes periodic national commodity studies to investigate current issues and examine general productivity, health, and management practices used on farms and their economic impact. These studies are driven by industry and stakeholder interest, and collect information that is not available from any other source (e.g., national estimates that are valid for the target population). Many industry stakeholders require current information on select swine diseases and pathogens to assess efforts to combat them and keep export markets open. Without this current study, APHIS would be unable to continue the trends analysis that began with the Swine 2007 and 2012 studies that various parts of the industry as well as many federal and state partners have come to rely on.

Further, the United States Animal Health Association (USAHA) resolved in 2018 that APHIS conduct a NAHMS swine study in 2020. The USAHA is an organization of state and federal animal health officials. This resolution, along with requests from the U.S. swine industry to APHIS to conduct a swine study in 2020 is driving the need to collect this information at this time.

In the nearly thirty years APHIS has conducted NAHMS swine studies the variety of study stakeholders has expanded, but the need for updated baseline national estimates regarding health and management of the national herd has not. Swine industry groups have stated this need. Previously, these national estimates were most often used to answer research questions posed by industry groups and academia. Now, in addition, these estimates are used in trade negotiations as a transparent snapshot of the US swine industry’s health status and structure. As trade agreements have resulted in additional revenue to producers, studies of this type need to be continued. VS is responding to the swine industry’s need by continuing these studies and by using the resultant data to focus resources and make scientifically based policy decisions.

2. 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.

Data collected, analyzed, and interpreted is disseminated to a wide variety of constituents. Producers can compare their operation’s animal health and productivity with other herds regionally and nationally. Producer groups, extension specialists and veterinarians will use summary estimates of disease and associated operation characteristics to improve disease preventive measures and information outreach efforts. Pharmaceutical and biologics companies will use vaccine and medication use estimates to develop research and marketing strategies for their products. State and Federal officials responsible for regulatory veterinary medicine will use estimates reflecting disease and disease prevention to gain a more complete picture of animal health as a basis for program planning and to direct funding. Research scientists will also use summary point estimates to design their research efforts. Veterinary and agricultural students in universities in the U.S. will use the reports for training in health management, animal welfare, nutrition, and other agriculturally based careers. Industry representatives will use these estimates as a transparent reference guide to the U.S. swine industry in trade negotiations.

APHIS will use the data collected from the study to:

• Predict or detect national and regional trends in disease emergence and movement such as the prevalence of clinical signs of Coronavirus (i.e., Porcine epidemic diarrhea or PED), Seneca Valley Virus, respiratory, and enteric disease in pigs,

• Provide factual information on housing, marketing and movement for smaller swine operations,

• Update national and regional production measures (such as average farrowing rate) for producer, veterinary, and industry reference,

• Provide factual information on antimicrobial resistance among isolates obtained from feces, and

• Provide assistance to researchers and the industry in evaluating the utility and accuracy of newer pathogen collection methods such as ropes to test saliva.

Data Collection Forms

VS Form 21-200, 2020 NAHMS Swine Large Enterprise Survey - Site Selection Form – will be administered by a NASS enumerator to select sites within an operations upon which the 2020 NAHMS Swine Large Enterprise Survey will be performed. The information on this paper form is used to compile a list of sites that raise breeding or weaned market pigs for the operation. A swine operation can have one or more sites on which swine owned by that site are raised. The site is the physical location where the hogs are.

VS Form 21-201, 2020 NAHMS Swine Large Enterprise Survey – A paper form that will be administered by a NASS enumerator to collect data on a producer’s site level swine inventory, management practices and preventive care practices.

VS Form 21-202, 2020 NAHMS Swine Large Enterprise Consent form – A paper form that will be administered by a NASS enumerator to producers who complete Phase I to obtain consent to be contacted by an APHIS-designated data collector for Phase II of the study. Upon completion, the form will be sent to the NASS Regional Field Office in the region the data collection was performed. The NASS Regional Field Officer will then transfer the consent forms to the APHIS-designated NAHMS State Coordinators within their region in person. APHIS only contacts participants who have consented to be contacted for Phase II.

VS Form 21-203, 2020 NAHMS Swine Large Enterprise - VS Visit – A paper form that will be administered by an APHIS-designated data collector to collect data on the site’s swine inventory numbers, how, what kinds, and for what reason do swine producers use vaccines, antibiotic usage, and management practices. Upon completion, the form (without producer contact information) is returned via U.S. Mail to APHIS in Fort Collins Colorado for data entry and validation, and a copy is retained by the data collector to facilitate validation. Once validation is complete, APHIS notifies data collectors to destroy their copies.

VS Form 21-204, 2020 NAHMS Swine Large Enterprise – Informed Consent – A paper form that will be presented to the participant by the APHIS-designated data collector upon entry into Phase II of the study. This form is designed to increase the participant’s understanding of the study focus, highlight confidentiality safeguards, and explain participation requirements and benefits. After completing the form with the participant, it will be signed by the participant and the APHIS-designated data collector so as to specify that data collection is allowed and what biologic incentives will be done. One copy of this agreement will be left with the participant and one copy will be retained by the APHIS-designated data collector. Once validation is complete, APHIS notifies data collectors to destroy their copies.

VS Form 21-205, 2020 NAHMS Swine Large Enterprise - Fecal Collection Form– A paper form that will be used by the APHIS-designated data collector to collect fecal samples from late finisher pigs (over twenty weeks of age). The form collects characteristics about pens sampled such as gender and vaccination status. The samples will be sent to a public university under cooperative agreement that will be selected prior to final submission for analysis. Test results will be returned to APHIS for analysis and reporting.

VS Form 21-206, 2020 NAHMS Swine Large Enterprise - Saliva Collection Form– A paper form that will be used by the APHIS-designated data collector to collect saliva of weaned market pigs. Like the fecal form, this form collects characteristics about pens sampled such as gender and vaccination status. The samples will be sent to a public university under cooperative agreement that will be selected prior to final submission for analysis. Test results will be returned to APHIS for analysis and reporting.

VS Form 21-207, 2020 NAHMS Swine Small Enterprise Survey – This paper form will be sent out to participants via U.S. Mail. If a response is not received two weeks after the initial mailing, a NASS data collector will call the producer to administer the questionnaire via Computer Assisted Telephone Interview (CATI). Approximately 5-10 calls will be made to attempt to administer the questionnaire (more if response rates are low and time is available). If no contact is made after sufficient attempts, the respondent will be coded as inaccessible. There will not be any attempt to convert refusals other than a clear explanation of the importance of their voluntary participation in the initial phone call. Data from all completed mail questionnaires will be entered in a database by NASS. The CATI responses will be directly incorporated into the same database and no hard copy record will be available. Edit/validation specifications will be prepared by APHIS and incorporated by NASS. More rigorous validation will be performed by NAHMS staff subsequent to receipt of the database from NASS. This form is used to collect data on the site level for swine inventory, management practices, preventive care, and marketing practices.

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.

No automated, electronic, or mechanical techniques will be used to collect information for the 2020 NAHMS Swine Large Enterprise Survey - Site Selection Form (VS Form 21-200) or the 2020 NAHMS Swine Large Enterprise Survey (VS Form 21-201). Electronic data capture may be available in place of a paper 2020 NAHMS Swine Large Enterprise - VS Visit (VS Form 21-203) questionnaire if desired by the collector but not for either of the biological collection forms. APHIS is currently working on fully implementing mobile data collection for questionnaires and is still limited on their capability. Since biological samples will be collected, an on-farm visit is required and provides an opportunity for the data collector to administer the questionnaire. The 2020 NAHMS Swine Small Enterprise Survey (VS Form 21-207) will be collected using CATI.

4. DESCRIBE EFFORTS TO IDENTIFY DUPLICATION. SHOW SPECIFICALLY WHY ANY SIMILAR INFORMATION ALREADY AVAILABLE CANNOT BE USED OR MODIFIED FOR USE FOR THE PURPOSE(S) DESCRIBED IN ITEM 2 ABOVE.

APHIS staff performed literature searches for existing data relevant to the 2020 Swine Study. Available data was reviewed and compiled from all known sources. Sources reviewed include; cooperative state research, private industry and professional publications, diagnostic laboratories, other Federal and State agencies, the National Pork Board, the National Pork Producers Council the American Association of Swine Veterinarians, and universities. The NAHMS study lead consulted employees from federal agencies, industry representatives, and academia to identify areas of potential duplication. Based on this effort, APHIS is convinced that no other entity/source is collecting and analyzing this type of nationally representative information regarding health and management of the U.S. swine industry with publically available results.

5. IF THE COLLECTION OF INFORMATION IMPACTS SMALL BUSINESSES OR OTHER SMALL ENTITIES (ITEM 5 OF THE OMB FORM 83-1), DESCRIBE THE METHODS USED TO MINIMIZE BURDEN.

The study will impact small businesses. Of the 9,968 total swine sites in the study sample, 5,880 are likely to meet the Federal Government standards outlined in the North American Industry Classification Systems Codes as a small business. Small businesses are measured by the Small Business Administration’s definition of a small agricultural business having receipts of $750,000 or less. The swine small enterprise component of this study, the part using the shorter questionnaire (VS Form 21-207), is designed to collect information from these small businesses/operations. This component is intended to collect the minimum amount of data required from a minimum number of swine producers to ensure statistically and scientifically valid data. Further, this component is implemented separately from the swine large enterprise component which utilize the rest of the forms in this study (VS Forms 21-201, 202, 203, 204, 205, 206). APHIS does not expect that any operation in the swine large operation component to be small businesses. This division minimizes the impact on small business by focusing on collecting the minimum information relevant to small swine operations and not including these operations in the more burdensome biologic sampling that are included in the large enterprise component. The total potential burden to the small business will not exceed 3,282 hours, 46% less than the total burden for large enterprises. This is a voluntary program. It is at the discretion of the individual swine producer to decide whether or not to participate.

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.

Failure to collect this information would negatively impact both the U.S. swine production industry and APHIS efforts to produce antimicrobial resistance data. APHIS has completed studies on the status of the U.S. swine industry in 1990, 1995, 2000, 2006, and 2012. Estimates derived from these studies, such as the average litter size, prevailing production practices, biosecurity and movement practices and frequency of health problems, are particularly useful to compare over time to demonstrate changes in U.S. swine production. Additionally, the biologic sample testing, oral fluids bank, and fecal isolates developed in this study will help APHIS to retrospectively examine the U.S. swine population. This type of information can be critical to better understand disease and to assist with trade negotiations. Without it the ability to respond to international trade issues involving the health status of the U.S. swine population would be severely reduced, jeopardizing the global marketability of pork.

7. 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 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 STATUE 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.

There are no special circumstances. This information collection is consistent with guidelines established in 5 CFR 1320.6.

8. IF APPLICABLE, PROVIDE A COPY AND IDENTIFY THE DATE AND PAGE NUMBER OF PUBLICATION IN THE FEDERAL REGISTER OF THE AGENCY'S NOTICE, REQUIRED BY 5 CFR 1320.8(d), SOLICITING COMMENTS ON THE INFORMATION COLLECTION PRIOR TO SUBMISSION TO OMB. SUMMARIZE PUBLIC COMMENTS RECEIVED IN RESPONSE TO THAT NOTICE AND DESCRIBE ACTIONS TAKEN BY THE AGENCY IN RESPONSE TO THESE COMMENTS. SPECIFICALLY ADDRESS COMMENTS RECEIVED ON COST AND HOUR BURDEN.

The Agency’s notice of information collection activity was announced in the Federal Register on Thursday, April 25, 2019 in Volume 84, No. 80, pages 17,375-17,376. APHIS received one public comment which was critical of APHIS in general and recommended not conducting the study. There were no specific changes suggested or requested and APHIS has not made any changes to the information collection. A copy of the Federal Register notice will be attached to final submission.

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. 

CONSULTATION WITH REPRESENTATIVES OF THOSE FROM WHOM INFORMATION IS TO BE OBTAINED OR THOSE WHO MUST COMPILE RECORDS SHOULD OCCUR AT LEAST ONCE EVERY 3 YEARS -- EVEN IF THE COLLECTION OF INFORMATION ACTIVITY IS THE SAME AS IN PRIOR PERIODS.  THERE MAY BE CIRCUMSTANCES THAT MAY PRECLUDE CONSULTATION IN A SPECIFIC SITUATION.  THESE CIRCUMSTANCES SHOULD BE EXPLAINED. 

Consultants used for the study are:

Dr. Abbey Canon, Director of Communications for the American Association of Swine Veterinarians, 830 26^th Street Perry, Iowa 50220 (515) 465-5255.

Dr. Canon provided valuable input on the design of the questionnaires and the study design. She has been involved with budget discussions and communication with the stakeholders regarding the study.

Dr. Lisa Becton, Director - Swine Health Information and Research, National Pork Board,

1776 NW 114th Street. Des Moines, Iowa 50325 (515) 223-2600.

Dr. Becton provided valuable input on both the design of the questionnaires, their content, scope, and depth of topics, and the study design.

Dr. Dave Pyburn, Senior Vice President of Science and Technology, National Pork Board,

1776 NW 114^th St. Des Moines, Iowa 50325 (515) 223-2600

Dr. Pyburn was the primary consultant regarding oral fluids in biologic sampling and how best to collect oral fluids efficiently in a way in which prevents waste of time and financial resources.

9. EXPLAIN ANY DECISION TO PROVIDE ANY PAYMENT OR GIFT TO RESPONDENTS, OTHER THAN REMUNERATION OF CONTRACTORS OR GRANTEES.

APHIS will provide no direct payments or gifts to respondents. The biological sampling provided to producers completing Phase II of the large swine producer component of this study does have a monetary value, valued at approximately $3,445 ($2,550 for oral fluid testing and $895 for fecal testing) per farm. This sampling is both a means of gathering valuable information concerning the presence and prevalence of important swine diseases and antibiotic resistance that cannot be provided via other means, but can also be seen as an incentive to participate as it can be used by the producer to gain a better understanding of the disease status of their animals and inform management decisions.

10. DESCRIBE ANY ASSURANCE OF CONFIDENTIALITY PROVIDED TO RESPONDENTS AND THE BASIS FOR THE ASSURANCE IN STATUTE, REGULATION, OR AGENCY POLICY.

Phase I (the NASS collection phase) and the questionnaire portion of Phase II (the APHIS collection phase, not including biological sampling) of the large enterprise component and all of the small enterprise component of this study will be collected under the Confidential Information protection and Statistical Efficiency Act (CIPSEA). Only the NASS or APHIS designated data collector collecting on-farm data will have knowledge of the participant’s identity. All forms, data, and reports will refer to the respondent by a numeric code, which is assigned by NASS. This link between participant and numeric code will be destroyed once data collection, entry, validation, and report dissemination are complete. All completed survey forms will be stored securely in a limited access records room.

The biological sample collection portion of Phase II (the APHIS collection phase) will not be protected under CIPSEA. Respondent information will be protected by ensuring that no identifying information is linked to the data outside of a secured, air-gapped data lab and is destroyed as soon as possible after data validation. Samples sent to cooperating labs will only have a unique participant ID and nothing else to identify where the sample came from. Only summary estimates based upon the inference population will be reported. All forms, data, and reports at APHIS will refer to the respondent by a unique numeric code, which is assigned by NASS. While every effort will be made to ensure respondent confidentiality, it is possible that information could be released as required by a Freedom of Information Act, or in the case of required disease reporting. However, names, addresses, and personal information will not be collected and therefore no connection can be made between a completed questionnaire or laboratory results and the respondent’s information. These confidentiality limitations will be explained on participation informed consent forms.

NASS has statutory protection that allows them to keep on-farm data (such as producer name and address information) confidential. Several U.S. Codes apply to data collected by NASS:

• Title 7, Section 2276 - Confidentiality of Information.

• Title 18, Section 1902 - Disclosure of Crop Information and Speculation Thereon.

• Title 18, Section 1905 - Disclosure of Confidential Information Generally.

There are also additional protections available through CIPSEA:

• Title V of E-Government Act of 2002, Public Law 107-347, Section 513. Fines and Penalties.

• Title V of E-Government Act of 2002, Public Law 107-347, Section 512. Limitations on Use and Disclosure of Data and Information.

Every NASS and APHIS employee or other individual that may handle a questionnaire, or data coming from a completed questionnaire, is required to sign a form governing certification and restrictions on use of unpublished data. Furthermore, once data are published, individuals are limited to the use of aggregate data files. Access to individual data files is restricted to maintain respondent confidentiality.

11. PROVIDE ADDITIONAL JUSTIFICATION FOR ANY QUESTIONS OF A SENSITIVE NATURE, SUCH AS SEXUAL BEHAVIOR AND 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.

APHIS has no questions of a sensitive nature in this collection activity.

12. PROVIDE ESTIMATES OF THE HOUR BURDEN OF THE COLLECTION OF INFORMATION. This is a two-part question and both parts must be addressed.

THE STATEMENT SHOULD:

• INDICATE THE NUMBER OF RESPONDENTS, FREQUENCY OF RESPONSE, ANNUAL HOUR BURDEN, AND AN EXPLANATION OF HOW THE BURDEN WAS ESTIMATED. UNLESS DIRECTED TO DO SO, AGENCIES SHOULD NOT CONDUCT SPECIAL SURVEYS TO OBTAIN INFORMATION ON WHICH TO BASE HOUR BURDEN ESTIMATES. CONSULTATION WITH A SAMPLE (FEWER THAN 10) OF POTENTIAL RESPONDENTS IS DESIRABLE. IF THE HOUR BURDEN ON RESPONDENTS IS EXPECTED TO VARY WIDELY BECAUSE OF DIFFERENCE IN ACTIVITY, SIZE, OR COMPLEXITY, SHOW THE RANGE OF ESTIMATED HOUR BURDEN, AND EXPLAIN THE REASONS FOR THE VARIANCE. GENERALLY, ESTIMATES SHOULD NOT INCLUDE BURDEN HOURS FOR CUSTOMARY AND USUAL BUSINESS PRACTICES.

• 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 estimates the total annualized cost to the respondents to be $241,549. APHIS arrived at this figure by multiplying the 11,166 total burden hours by the respondents’ estimated average hourly wage of $14.71, and then multiplying the result by 1.4706 to capture benefit costs.

The wage estimate was obtained from the May 2017 Occupational Employment and Wages report from the Bureau of Labor Statistics (BLS; https://www.bls.gov/news.release/pdf/ocwage.pdf) and is supported by the 2018 NASS Farm Labor report (https://downloads.usda.library.cornell.edu/usda-esmis/files/x920fw89s/9g54xm59d/j96024106/fmla1118.pdf).  According to DOL BLS news release USDL-18-1499, dated September 18, 2018 (https://www.bls.gov/news.release/pdf/ecec.pdf), benefits account for 32% of employee costs, and wages account for the remaining 68%.  Mathematically, total costs can be calculated as a function of wages using a multiplier of 1.4706.

For more specific information, please see the enclosed APHIS 71 form.

13. PROVIDE AN ESTIMATE 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 ESTIMATE 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. THE ESTIMATES SHOULD TAKE INTO ACCOUNT COSTS ASSOCIATED WITH GENERATING, MAINTAINING, AND DISCLOSING OR PROVIDING THE INFORMATION. INCLUDE DESCRIPTIONS OF METHODS USED TO ESTIMATE MAJOR COST FACTORS INCLUDING SYSTEM AND TECHNOLOGY ACQUISITION, EXPECTED USEFUL LIFE OF CAPITAL EQUIPMENT, THE DISCOUNT RATE(S), AND THE TIME PERIOD OVER WHICH COSTS WILL BE INCURRED. CAPITAL AND START-UP COSTS INCLUDE, AMONG OTHER ITEMS, PREPARATIONS FOR COLLECTING INFORMATION SUCH AS PURCHASING COMPUTERS AND SOFTWARE; MONITORING, SAMPLING, DRILLING AND TESTING EQUIPMENT; AND RECORD STORAGE FACILITIES.

• IF COST ESTIMATES ARE EXPECTED TO VARY WIDELY, AGENCIES SHOULD PRESENT RANGES OF COST BURDENS AND EXPLAIN THE REASONS FOR THE VARIANCE. THE COST OF PURCHASING OR CONTRACTING OUT INFORMATION COLLECTION SERVICES SHOULD BE A PART OF THIS COST BURDEN ESTIMATE. IN DEVELOPING COST BURDEN ESTIMATES, AGENCIES MAY CONSULT WITH A SAMPLE OF RESPONDENTS (FEWER THAN 10), UTILIZE THE 60-DAY PRE-OMB SUBMISSION PUBLIC COMMENT PROCESS AND USE EXISTING ECONOMIC OR REGULATORY IMPACT ANALYSIS ASSOCIATED WITH THE RULEMAKING CONTAINING THE INFORMATION COLLECTION, AS APPROPRIATE.

• GENERALLY, ESTIMATES SHOULD NOT INCLUDE PURCHASES OF EQUIPMENT OR SERVICES, OR PORTIONS THEREOF, MADE: (1) PRIOR TO OCTOBER 1, 1995, (2) TO ACHIEVE REGULATORY COMPLIANCE WITH REQUIREMENTS NOT ASSOCIATED WITH THE INFORMATION COLLECTION, (3) FOR REASONS OTHER THAN TO PROVIDE INFORMATION OR KEEPING RECORDS FOR THE GOVERNMENT, OR (4) AS PART OF CUSTOMARY AND USUAL BUSINESS OR PRIVATE PRACTICES.

There are no capital/startup costs or ongoing operations and maintenance costs for respondents or record keepers associated with this information collection. Questions in this study may reference swine operation or site production records, but APHIS does not require producers to maintain or provide these records to answer questions.

14. PROVIDE ESTIMATES OF ANNUALIZED COST TO THE FEDERAL GOVERNMENT. ALSO, PROVIDE A DESCRIPTION OF THE METHOD USED TO ESTIMATE COST, WHICH SHOULD INCLUDE QUANTIFICATION OF HOURS, OPERATION EXPENSES (SUCH AS EQUIPMENT, OVERHEAD, PRINTING, AND SUPPORT STAFF), AND ANY OTHER EXPENSE THAT WOULD NOT HAVE BEEN INCURRED WITHOUT THIS COLLECTION OF INFORMATION. AGENCIES ALSO MAY AGGREGATE COST ESTIMATES FROM ITEMS 12, 13, AND 14 IN A SINGLE TABLE.

The estimated cost to the Federal Government for the study is $2,797,722. For more specific information, please see the enclosed APHIS 79 form.

15. EXPLAIN THE REASON FOR ANY PROGRAM CHANGES OR ADJUSTMENTS REPORTED IN ITEMS 13 OR 14 OF THE OMB FORM 83-1.

This is a reinstatement of a previous collection to investigate current issues and examine general health and management practices of swine used on farms. The information collected through this study will be used by APHIS to identify the prevalence of risk factors for reintroduction of diseases in the population at risk and provide starting estimates and distributions for simulation modeling of program diseases. Form numbers were changed and initiated from VS to comply with APHIS standards. A CATI was planned to include smaller operations.

PREVIOUS NEW TYPE OF

REG. NO. REASON BURDEN BURDEN DIFFERENCE CHANGE

Number in 0 11,166 hr. 11,166 hr. P

Sample

Number of

Respondents 0 9,965 9,965 P

Annual

Responses 0 9,125 9,125 P

Change

Total Cost 0 $2,797,722 $2,797,722 P

16. FOR COLLECTIONS OF INFORMATION WHOSE RESULTS WILL BE PUBLISHED, OUTLINE PLANS FOR TABULATION, AND PUBLICATION. ADDRESS ANY COMPLEX ANALYTICAL TECHNIQUES THAT WILL BE USED. PROVIDE THE TIME SCHEDULE FOR THE ENTIRE PROJECT, INCLUDING BEGINNING AND ENDING DATES OF THE COLLECTION OF INFORMATION, COMPLETION OF REPORT, PUBLICATION DATES, AND OTHER ACTIONS.

APHIS will summarize information from this survey immediately following the data collection and validation phase. Phase I data collection is planned to take place between July, 2020 and August, 2020 and Phase II data collection is planned to take place between October, 2020 and January, 2021. APHIS employees will enter data into a database management system utilizing workstations. APHIS statisticians will perform statistical calculations such as descriptive statistics including frequency distribution, prevalence, and point estimates. APHIS statisticians will calculate variance measures and confidence intervals for the point estimates in order to describe the precision of the descriptive statistics generated. APHIS statisticians will utilize SAS survey procedures and/or SUDAAN software from RTI to correctly calculate the standard error to account for the complex study design. The APHIS study lead will publish standard errors and point estimates for aggregated statistical measures.

The first study publication, a descriptive report using information collected during Phase I, will be released in Summer of 2021. A descriptive report using information collected during Phase II will be published in Winter of 2021. A descriptive report using information collected via CATI from the small enterprise operations will be released in Fall of 2021. Informational sheets using descriptive statistics and manuscripts using descriptive statistics and inferential statistics will be released after Spring of 2022.

APHIS strives at reducing the time between the end of data collection and release of a final publication. Tableau dashboard visualizations and hardcopy information from the study will be made available to swine producers, universities, researchers, practitioners, animal health related industries, Federal agencies, legislators, and any other interested parties. Copies of current and past information sheets from the NAHMS are available at: https://www.aphis.usda.gov/nahms.

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 is not seeking approval to not display the expiration date for OMB approval on the forms used in this collection.

18. EXPLAIN EACH EXCEPTION TO THE CERTIFICATION STATEMENT IDENTIFIED IN ITEM 19, "CERTIFICATION FOR PAPERWORK REDUCTION ACT SUBMISSIONS," OF OMB FORM 83-1.

APHIS is able to certify compliance with all provisions under the Act.

1 Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Carolina, Ohio,

Oklahoma, Pennsylvania, and South Dakota.

2 Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin.