0579-0474 Fr Ss

DRAFT

October 2020

SUPPORTING STATEMENT

NATIONAL POULTRY IMPROVEMENT PLAN and AUXILIARY PROVISIONS

APHIS DOCKET 18-062-1

OMB No. 0579-0474

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.

The National Poultry Improvement Plan (NPIP) is a voluntary Federal-State-industry mechanism for controlling certain poultry diseases and for improving poultry breeding flocks and products through disease control techniques. The NPIP became operative on July 1, 1935, with the approval of the Secretary of Agriculture and under the authority of a Congressional appropriation for the U.S. Department of Agriculture (USDA) to use with State authorities to administer regulations to improve poultry, poultry products, and hatcheries.

The National Turkey Improvement Plan was combined with the NPIP in 1970 to create the current NPIP. Emu, rhea, ostrich, and cassowary breeding flocks are also allowed to participate in the Plan.

This program is authorized by the USDA Organic Act of 1944, as amended (7 U.S.C. 429). The cooperative work is carried out through Memoranda of Understanding with the participating States. Specific NPIP provisions are contained at parts 56, 145, 146, and 147 of Title 9, Code of Federal Regulations. The Veterinary Services unit (VS) of USDA's Animal and Plant Health Inspection Service (APHIS) administers these regulations.

The NPIP also contains provisions that allow it to update and revise its regulations through biennial meetings of its General Conference Committee (GCC). After its 2018 conference, the GCC added provisions for Newcastle disease (NDv) flock certification and compartmentali-zation, including testing, diagnosing, flock management, identification, auditing, biosecurity, surveillance, and indemnity. This information collection addresses these added activities, as well as the NPIP Initial State Response and Containment Plan.

APHIS amended its regulations to allow it to better survey and detect outbreaks of Newcastle disease (NDv). These amendments provide a basis from which the breeding-hatchery industry may conduct a program to prevent and control Newcastle disease (hereinafter the “Newcastle Clean program”). APHIS intends to determine the presence of Newcastle disease virus through vaccination and monitoring of each participating breeding flock.

APHIS is asking the Office of Management and Budget (OMB) to approve for three years its use of these information collection activities associated with its efforts to manage the Newcastle Disease in the United States.

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 activities to continually improve the health of the U.S. poultry population and the quality of U.S. poultry products.

Flock Selecting and Testing Report (AI and ND) (VS Form 9-2); (9 CFR 145.43h, .73h, and .83h); (State, Business)

The identification and testing of poultry for diseases is recorded on VS Form 9-2. A flock and its hatching eggs and poults/chicks produced from it may qualify for the Newcastle Clean program if they meet certain requirements. Flock owners wishing to participate must monitor the flocks for antibody response using approved serological tests as listed in 9 CFR 145.14 with results compatible with immunological response against ND vaccination. Owners must test a minimum of 30 birds with a serological monitoring program beginning at approximately 10 weeks when more than 4 months of age and prior to the onset of production, and not longer than every 90 days thereafter.

To retain classification for unvaccinated flocks, owners must:

• Have at least 30 birds per flock test negative using an approved test in 9 CFR 145.14 at intervals of 90 days; or

• Test a sample of fewer than 30 birds, with negative results, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and

• During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to NDv within 21 days prior to movement to slaughter.

Birds must originate from flocks that were vaccinated for NDv using licensed vaccines and compliant with a program to evaluate serological response to NDv vaccination; or, if unvaccinated, have tested negative to NDv.

Application For U.S. Avian Influenza and Newcastle Disease Clean Compartment Registration (VS Form 9-20); (9 CFR 145.45a, .74a, and .84a); (State, Business)

Compartmentalization applicants must complete this form and submit it for signature to the Official State Agencies of the States in which they operate. The last signing Official State Agency tenders the form to the NPIP, which reviews and determines whether to register the applicant and arrange for an audit. The form requires the following information:

• Company name and mailing address.

• Contact name, telephone number, and alternate contact number.

• Contact fax number and email address.

• Company NPIP classification (US AI Clean or US AI H5/H7 clean).

• Breed/type of poultry.

• NPIP Classification seeking.

• Compartment mailing address.

• Compartment location (listing all involved States).

• Name of compartment.

• Anticipated type of components (farm, feedmill, hatchery, and egg depot) to add within the compartment.

Applicants must also certify that their operation meets all general and specific management protocols. Further, they must certify that they:

• Are participants in good standing with the NPIP.

• Compliant with all of the management procedures, physical requirements, and protocols found in the CFR and the NPIP Program Standards document.

• Located in a State or States with an APHIS-approved Initial State Response and Containment Plan (ISRCP) (9 CFR 56.10).

• Perform routine surveillance of all flocks within the compartment in a NPIP-authorized laboratory.

The primary breeding company’s veterinary infrastructure assessessanitary measures, environ-mental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may affect risk of exposure to H5/H7 AI and NDv. This assessment must include a description of internal monitoring and auditing systems (e.g., quality assurance and quality control programs) to demonstrate the effectiveness of the compartment. APHIS and the Official State Agency use this documentation to approve or deny the classification of the compartment as U.S. Avian Influenza and NDV Clean.

Functional relationships between components of the compartment include traffic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect the compartment’s biosecurity. All physical components of the compartment must be maintained in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with 9 CFR part 147, and this must be documented in paperwork provided to APHIS so it can monitor the accredited flock’s compliance with the requirements.

Application For U.S. Avian Influenza and Newcastle Disease Clean Compartment Component Registration (VS Form 9-21); (9 CFR 145.45a, .74a, .84a); (State, Business)

Applicants for compartmentalization must also submit an application form listing all the different components (farm, feedmill, hatchery, and egg depot) to be included in their compartment. Form B, like Form A, must be submitted to the Official State Agencies for review and signature before submission to NPIP, and requires the same company contact information and NPIP compliance verification. In addition, the form asks whether the components are new facilities within a certified compartment; whether requalification for the component is due; or whether components previously removed from a certified compartment are to be reinstated. The applicant then has to list the numbers of each kind of component to be registered, and provide the components’ names, site plans, specifications, and management protocols.

The primary breeder company must provide documentation establishing that the defined compartment is epidemiologically separated from other poultry and bird populations. The documentation must be approved by the NPIP Official State Agency and APHIS as indicating adequate epidemiological separation to maintain the compartment's separate health status with respect to H5/H7 avian influenza (AI) as well as NDv. The documentation should include descriptions of:

• The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment.

• Relevant environmental factors that may affect exposure of the birds to AI and NDv.

• The functional boundary and fencing used to control access to the compartment.

• Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts.

• The relevant infrastructural factors that may affect exposure to AI and NDv, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment.

The primary breeder company's management of biosecurity, surveillance, and disease control efforts must be uniform and equivalent among all compartment components. The company’s licensed, accredited veterinarians must oversee and inspect these management practices.

Application For U.S. Avian Influenza and Newcastle Disease Clean Compartment Component Removal (VS Form 9-22); (9 CFR 145.45a, 145.74a, 145.84a); (State, Business)

A compartment wishing to remove a component must file Form C with both the applicable Official State Agencies and the NPIP. The form calls for the same company contact and NPIP compliance verification information as Forms A and B, as well as a specific list of the reasons for requesting removal.

Component Audit; (9 CFR 145.45a, 145.74a, 145.84a); (Business)

Components are audited by NPIP-certified auditors on a periodic basis to ensure continual compliance with NPIP standards.

Veterinary staff from the Official State Agency and NPIP staff work with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors conduct biosecurity and operational audits to ensure the compartment’s integrity. These audits include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment. The audits:

• Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures.

• Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they comply with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with 9 CFR part 147.

The company must also demonstrate compliance with requirements for remaining in the U.S. Avian Influenza and NDV Clean classifications, surveillance for H5/H7 AI and NDv within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians must enforce active and passive surveillance of H5/H7 AI and NDV in primary breeder flocks. The company must maintain baseline health status for all compartment flocks or subpopulations, indicating the dates and negative results of all avian influenza and NDv surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control applied. Producers must keep documentation on the company's database. APHIS and the Official State Agency verify retention of surveillance and testing documentation.

Compliance Statement; (9 CFR 145.45a, .74a, .84a); (State)

APHIS works with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities include:

• Oversight of the establishment and management of compartments.

• Establishment of effective partnerships between APHIS, NPIP, and the primary breeder industry.

• Approval or denial of classification of compartments as U.S. Avian Influenza and NDV Clean Compartments.

• Official certification of the health status of the compartment, and commodities that may be traded from it through participation in NPIP for avian diseases, including the U.S. Avian Influenza Clean program as described in 9 CFR 145.43(g), 145.73(f), and 145.83(g); the NDV Clean program as described in 9 CFR 145.43(h), 145.73(h), and 145.83(h); and diagnostic surveillance for H5/H7 low pathogenicity AI (LPAI) as described in 9 CFR 145.15.

• Conducting audits as described above.

• Providing, on request, model plans for management and husbandry practices relating to biosecurity in accordance with 9 CFR part 147, risk evaluations with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with 9 CFR 56.10 (see below).

Description of Animal ID and Traceability Processes; (9 CFR 145.45a, .74a, .84a); (Business)

A primary breeder company wishing to become NDv certified must provide APHIS with a description of its animal identification and traceability records. Documentation must also include breed identification (NPIP stock code). Providing this information allows APHIS to ensure that the company has an effective flock identification system and traceability system in place.

Laboratory Examination for NDv and Reporting; (9 CFR 145.43h, .73h, .83h); (Business)

All licensed veterinarians in a State must report NDv outbreaks to the responsible State authority. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for NDv.

ND Biosecurity Plan; (9 CFR 145.45a, .74a, .84a); (Business)

The primary breeder company must provide a biosecurity plan for the compartment and all included components. The biosecurity plan should include:

• Requirements that company employees and contract growers limit their contact with live birds outside the compartment.

• An education and training program for company employees and contractors.

• Standard operating procedures for company employees, contractors, and outside maintenance personnel.

• Requirements for company employees and non-company personnel who visit any premises within the compartment.

• Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures.

• Policies for managing vehicles and equipment used within the compartment to connect the various premises.

• Farm site requirements (location, layout, and construction).

• Pest management program (insect and rodent eradication and control).

• Cleaning and disinfection processes.

• Requirements for litter and dead bird removal and/or disposal.

• Sanitation policies, including procedures for managing feed and water supplies.

Recordkeeping; (9 CFR 145.4, 145.45, .74, .84); (State)

The records of all flocks maintained primarily to produce hatching eggs must be examined annually by a State inspector. These records must be maintained for 3 years.

Indemnity Compliance Agreement (9 CFR 56.4); (State, Business)

Any disposal of poultry infected with or exposed to H5/H7 LPAI for which indemnity compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS reviews claims for indemnity compensation for disposal to ensure that all expenditures relate directly to activities described in 9 CFR 56.5 and in the initial State response and containment plan described in 9 CFR 56.10 and below. If disposal is performed by the Cooperating State Agency, APHIS will compensate the Cooperating State Agency for disposal under a cooperative agreement.

The compliance agreement is a comprehensive document that describes the depopulation, disposal, and cleaning and disinfection plans for poultry infected with or exposed to H5/H7 LPAI, or a premises that contained such poultry. The compliance agreement sets out cost estimates that include labor, materials, supplies, equipment, personal protective equipment, and any additional information APHIS deems necessary. The compliance agreement indicates what tasks will be completed, who will be responsible for each task, and how much the work is expected to cost. Once work associated with the compliance agreement is completed, receipts and documentation detailing the activities specified in the agreement should be forwarded to APHIS for review, approval, and final payment. This documentation should be submitted to APHIS no later than 30 days after the quarantine release of the affected or exposed premises.

Appraisal and Indemnity Claim for Animals Destroyed or Materials Destroyed

(VS Forms 1-23, 1-24, and 1-26)); (9 CFR 56.4); (State, Business)

VS Forms 1-23, 1-24, and 1-26 are included as placeholders in the event a highly pathogenic avian influenza or similar disease outbreak occurs in the poultry industry. The forms record appraisals made and approved for payment to owners or claimants. They are completed by either personnel from the State VS office or a Federal and State approved appraiser (usually a Federal employee) with input from the flock owner. The forms are signed by both the appraiser and the owner and list:

• Premises information: name, identification number, where birds are located (address, city, county, State, ZIP code).

• Claimant full legal name and address (the claimant may be the poultry owner and/or contract grower, as applicable).

• Claimant Data Universal Number System (DUNS) number and confirmation that the claimant has registered in the Federal System for Award Management (SAM). For electronic payment processing, the claimant name on the VS 1-23 must be the same as the vendor name associated with the DUNS number provided.

• Confirmation of mortgage status (claimant initials required): If there is a mortgage, the form must also be signed by each person holding a mortgage. By signing the form, each mortgage holder is consenting to the payment of indemnity to the owner or lien holder.

• Appraisal Date: For indemnified birds and eggs, this is the date that the appraisal values are assigned to the birds or eggs (usually the presumptive positive date). For indemnified materials, this is the date that the fair market value was determined.

• For indemnified birds and eggs, detailed specific flock information as described in the Appraisal and Indemnity Request Form (flock type, age, sex, inventories, organic status, number of animals/eggs for which the owner is seeking payment, and the appraised value of each animal/lot of eggs using criteria specific to each type of poultry/flock).

• The date of cleaning and disinfection.

• Country Code

• Congressional District, if known (often APHIS personnel must add this later)

• A statement (yes or no) where the recipient attests that this is the only payment received for this incident. If “no,” APHIS needs to know who provided the additional payment, how much was received, and the date. APHIS would then reduce the indemnity payment by that amount.

If applicable, separate forms are prepared for owners and growers. APHIS personnel obtain the claimant’s signature (poultry owner and/or contract grower). If payment is to be split, the owner and the grower will sign separate forms. The signatures indicate agreement with the appraised value of each animal. The appraiser also signs the form.

Initial State Response and Containment Plan; (9 CFR 56.10); (State)

For poultry owners within a State to be eligible for indemnity and/or compensation for up to 100 percent of eligible indemnity costs, the State in which the poultry participate in the Plan must have in place an initial State response and containment plan approved by APHIS. The initial State response and containment plan must be developed by the Official State Agency. In States where the Official State Agency is different than the Cooperating State Agency, the Cooperating State Agency must also participate in the development of the plan. The plan must be administered by the Cooperating State Agency of the relevant State. This plan must include:

• Provisions for a standing emergency disease management committee, regular meetings, and exercises, including coordination with any affected Tribal governments.

• A minimum biosecurity plan followed by all poultry producers.

• Provisions for adequate diagnostic resources.

• Detailed, specific procedures for initial handling and investigation of suspected cases of H5/H7 LPAI.

• Detailed, specific procedures for reporting test results to APHIS. These procedures must be developed after appropriate consultation with poultry producers in the State and must provide for the reporting only of confirmed cases of H5/H7 LPAI in accordance with 9 CFR 146.13.

• Detailed, strict quarantine measures for presumptive and confirmed index cases.

• Provisions for developing flock plans for infected and exposed flocks.

• Detailed plans for disposal of infected flocks, including preexisting agreements with regulatory agencies and detailed plans for carcass disposal, disposal sites, and resources for conducting disposal, and detailed plans for disposal of materials that come into contact with poultry infected with or exposed to H5/H7 LPAI.

• Detailed plans for cleaning and disinfection of premises, repopulation, and monitoring after repopulation.

• Provisions for appropriate control/monitoring zones, contact surveys, and movement restrictions.

• Provisions for monitoring activities in control zones.

• If vaccination is considered as an option, a written plan for use in place with proper controls and provisions for APHIS approval of any use of vaccine.

• Plans for H5/H7 LPAI-negative flocks that provide for quarantine, testing, and controlled marketing.

• Public awareness and education programs regarding avian influenza.

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.

APHIS plans to add the documents and information requests to the NPIP database at www.poultryimprovement.org. VS Forms 9-20, 9-21, and 9-22 will be available on the NPIP website. APHIS is currently working on standardizing the format of these forms and making them PDF fillable.

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 preventing the entry of exotic animal and poultry diseases into the United States.

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

APHIS estimates approximately 5 percent of the business respondents are considered small entities. The information APHIS collects is the minimum needed to protect the U.S. poultry population from communicable diseases.

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 were collected less frequently or not collected, APHIS could not effectively monitor the health of the nation's poultry population.

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 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.

There are no special circumstances associated with this information collection. This information collection is conducted in a manner consistent with the guidelines established 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.

APHIS engaged in productive consultations with the following individuals in connection with the information collection requirements associated with this program:

Dr. Alberto Torres

Cobb-Vantress, Inc.

PO Box 1030

Siloam Springs, AR 72761

P: 479-549-2813

F: 479-717-0351

[email protected]

Dr. Eric Gonder, staff veterinarian

Butterball, LLC

P.O. Box 10009

Goldsboro, NC 27532-0009

Phone: (919) 778-3130, ext. 1239

Email: [email protected]

Dr. Julie Helm

Clemson University

P.O. Box 102406

Columbia, SC 29224

Phone: 803-788-2260

Fax: 803-788-8058

[email protected]

APHIS contacted these respondents by email and phone to discuss the information APHIS collects to manage NDv and compartmentalization. We discussed with them how we and they obtain the necessary data and how frequently; how much data is available; the convenience and clarity of reporting formats and other collection instruments; and the clarity of, and necessity for, any recordkeeping requirements. The respondents stated via email or phone that they had no concerns with any of these items and had no further recommendations.

APHIS published the proposed rule in the Federal Register on December 5, 2019 (under APHIS docket number APHIS-2018-062). The proposed rule includes a 60-day comment period during which interested members of the public will have the opportunity to provide APHIS with their input concerning the usefulness, legitimacy, and merit of the information collection activities APHIS is proposing. APHIS received 12 comments from the public and each are addressed in the final rule. None resulted in changes to this information collection request.

9. Explain any decision to provide any payment or gift to respondents, other than re-enumeration 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.

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 83-1.

See APHIS Form 71. Burden estimates were developed from discussions with poultry producers and State agricultural employees who assist with the program.

• 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 $2,123,545. APHIS arrived at this figure by multiplying the hours of estimated response time (43,810 hours) by the estimated average hourly wage of the above respondents ($33.92) and then multiplying the result by 1.429 to capture benefit costs.

The hourly rate is derived from the U.S. Department of Labor, Bureau of Labor Statistics May 2018 Report − Occupational Employment and Wages in the United States, found at http://www.bls.gov/news.release/pdf/ocwage.pdf: agricultural managers: $38.63 (Flock owners, breeders, hatchery operators, and table egg producers), slaughterers and meat packers: $13.68, animal scientists: $32.96 (Personnel at approved laboratories), and State veterinarians: $50.39.

According to DOL BLS news release USDL-20-0451 released March 19, 2020, employee 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 using a multiplier of 1.429.

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.

Businesses reimburse APHIS for the audits they receive. The average cost for a complete audit is $70,000 and the agency averages three per year for a total of $210,000.

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 Form 79. The annual cost to the Federal government is estimated to be $793,850.

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

This is a new request related to rulemaking. It has 1,361 respondents, 23,857 responses, and 43,810 hours of burden, all of it discretionary due to amendment of the Code of Federal Regulations.

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

None.

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.

The VS Forms 1-23, 1-24, and 1-26 are used in multiple information collections. It would not be 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 these

forms. Also, APHIS is exploring creating one information collection for animal and animal product indemnity which will include these forms. It is also considering making these forms common forms.

VS Forms 9-2 are currently bulk produced in paper format. APHIS requests an expiration date not be included on the forms to preclude having obsolete stocks on hand at the next information collection renewal. Rendering the forms obsolete because of the date would be wasteful; further, managing a form’s OMB IC expiration date as well as its version date unnecessarily complicates form management efforts.

VS Forms 9-20, 9-21, and 9-22 will be posted to the NPIP online website for downloading. APHIS requests an expiration date not be included on the forms to preclude users from downloading and locally storing a form that may accidentally become obsolete at the next information collection renewal. Applying a PRA IC expiration date as well as a form version date unnecessarily complicates form management efforts.

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

APHIS is able to certify compliance with all the 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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