0189 2021 Ss

August 2021

SUPPORTING STATEMENT

Control of Chronic Wasting Disease

OMB No. 0579-0189

TERMS OF CLEARANCE: “Before this ICR is renewed, USDA should consider converting VS Form 10-4 to a common form and establishing a single OMB control number for it.” APHIS has made little progress in converting its multi-ICR agency forms to common forms. It has many forms eligible for conversion but has lacked the expertise and time to develop a process for converting and managing them efficiently. The Agency anticipates making material progress on this project in 2021.

This information collection includes new burden.

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; it gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict the import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 8301 et. seq.).

Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the United States’ ability to compete in the world market of animal and animal product trade. The presence of chronic wasting disease (CWD) in cervids causes significant economic and market losses for U.S. producers.

CWD is a transmissible spongiform encephalopathy of elk, deer, and moose typified by chronic weight loss leading to death. To accelerate the control of this disease and limit its spread in the United States, APHIS created a cooperative, voluntary Federal-State-private sector CWD Herd Certification Program. The program is designed to identify farmed or captive herds infected with CWD and provide for the management of these herds in a way that will reduce the risk of spreading CWD.

Under Title 9, Code of Federal Regulations (9 CFR) Part 55 and 9 CFR Part 81, owners of elk, deer, and moose herds who choose to participate in this program must follow program requirements for animal identification, testing, herd management, and movement of animals into and from herds. Regulations further establish requirements for the interstate movement of cervids to prevent movement of animals that pose a risk of spreading CWD.

APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities in connection with its efforts to identify, prevent, and control CWD 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 identify, prevent, and control CWD in the United States:

Memorandum of Understanding Between States and APHIS Animal Health Authorities

(9 CFR 55.23(a)) (State)

To enter their States into the State-Federal Cooperative CWD Herd Certification Program (HCP), State animal health authorities must enter into a memorandum of understanding (MOU) between APHIS and the State. The MOU delineates the respective roles of each in the program's implementation. A signed MOU is required to enroll in the HCP, amend the State’s status, and renew the MOU at least every 5 years to maintain participation.

Application for Chronic Wasting Disease Herd Certification Program (CWD HCP) Approval, Renewal, or Reinstatement of a State (previously titled Participation Request/Application Package) (VS Form 11-2); (9 CFR 55.22(b), 23(a)); (Business (Herd Owners in States Without a State CWD Herd Certification Program), State)

If a State Herd Certification Program does not exist, herd owners of farmed/captive cervids may apply to enter the national CWD Herd Certification Program directly by submitting to APHIS a completed VS Form 11-2. However, APHIS’ ability to accept direct entry is based on availability of Federal funding. Applications need only be submitted once. Once enrolled in the program, the owner may use the VS Form 11-2 for renewal.

Any State that operates a State program to certify the CWD status of deer, elk, or moose may use the VS Form 11-2 to ask APHIS to designate the State program as an Approved State CWD Herd Certification Program. The form asks for an inventory of enrolled herds in the State by species; the number of animals tested through on-farm surveillance, at slaughter, and at hunt facilities; and includes certification that the State meets the HCP requirements. For renewals or reinstatements, the form provides a space for any action items identified during an approved State review or for the previous renewal. The State must submit its request, as well as a copy of the State’s program and other documentation, to APHIS for review before APHIS approves or disapproves a State program in accordance with 9 CFR 55.23(a). Once a State program is approved, the State must submit a complete VS Form 11-2 as part of its annual report to renew status.

Lab Submission Reports and Sample Collection, Lab Submission and Testing (VS Form 10-4 or equivalent); (9 CFR 55.23(a), (b); 55.8); (Business (Herd Owner and Approved Laboratory), State)

Accredited veterinarians, APHIS employees, State officials, and certified sample collectors collect samples of cervid tissue to submit to approved laboratories for testing. All sample

containers must have labels containing the date of collection, the producer’s name, the animal’s species and official ID number, the type of specimen, and the sample ID number, and be submitted with either VS Form 10-4 or an equivalent CWD laboratory submission form. These same people report the test results back to the owners and submitters. If the laboratory results are a suspected positive, the sample is forwarded to the APHIS National Veterinary Services Laboratories (NVSL) for confirmation. The NVSL reports the test results to the submitting approved testing laboratory, the APHIS Veterinary Services District office, and the national CWD program staff. The District office forwards a copy of the report to the Approved State.

Farmed/Captive Cervid Identification; (9 CFR 55.25; 81.2); (Business); (Third Party Disclosure)

Each animal in a participating herd must be identified with at least two forms of identification, one of which is a unique USDA official identification number. The identification may be applied by the herd owner or the owner's agent and must be linked to that herd in the appropriate State database. APHIS does not maintain a national CWD database. The second form of identification must uniquely identify the animal within the herd.

Report of Cervid Disappearances, Escapes, and Deaths; (9 CFR 55.23(b)(3)); (Business, (State)

Herd owners must immediately report to an APHIS employee or State representative all animals that escape or disappear, and all deaths (to include for those killed on premises maintained for hunting and animals sent to slaughter) of deer, elk, and moose in the herd aged 12 months or older. APHIS employees or State representatives may approve reporting schedules other than immediate notification when herd conditions warrant it in the opinion of both APHIS and the State. Herd owners will notify APHIS or State officials to determine if an animal is suspected of exhibiting clinical signs suggesting CWD infection.

Herd or Premises Plans; (9 CFR 55.1); (Business, State)

When CWD is discovered in a captive cervid herd, the owner must participate in a herd or premises plan. A herd plan must be signed by the owner and be in place before a herd can re-enroll in the CWD Herd Certification Program after losing program status. It also must be completed before quarantine can be removed. APHIS helps develop this written management plan with input from the herd owner and State animal health authorities. The plan describes the steps to be taken to control spread of CWD from a CWD-positive herd, or to prevent the introduction of CWD into another herd.

A herd plan requires specified means of identification for each animal in the herd; regular examination of animals in the herd by a veterinarian for signs of disease; reporting to a State or APHIS representative any signs of central nervous system disease in herd animals; maintaining records of the acquisition and disposition of all animals entering or leaving the herd, including the date of acquisition or removal; the name and address of the person from whom the animal was acquired or to whom it was disposed, cause of death; and whether the animal died while in the herd.

A herd plan may also contain additional requirements to prevent or control the possible spread of CWD depending on the particular condition of the herd and its premises, including but not limited to herd depopulation; specifying the time for which a premises must not contain cervids after CWD-positive, CWD-exposed, or CWD-suspect animals are removed from the premises; fencing requirements; selective culling of animals; restrictions on sharing and movement of possibly contaminated livestock equipment; and cleaning and disinfecting requirements.

Annual Reports for Herd Certification Program (HCP) Renewal; (9 CFR 55.23(a)); (State)

Comprehensive annual reports of Herd Certification Program status and activities of enrolled herds are submitted by the Approved States to APHIS each year to renew their status. States use the VS approved-spreadsheet and additional pages as needed to include information related to numbers of enrolled herds by State, herd status summaries, and summary of the level of mortality surveillance (including the number of annual inspections and inventories, and any herds reporting missing animals or with lowered or suspended status). The reports also include (1) CWD samples and tests – number of animals tested during the reporting period, species, herd type (breeder, hunting operation, etc.) and test results; (2) any CWD-positive herds – under quarantine, depopulated and released from quarantine, not under quarantine, under herd plans, and the number of animals in each herd; (3) any CWD-exposed herds – under quarantine, depopulated and released from quarantine, not under quarantine, under herd plans, and the number of animals in each herd; (4) epidemiological information – traceouts initiated, traceouts pending, and traceouts completed; and (5) number of enrolled herds – by State and certification status, species, number of animals in each herd, number due for inspection during each reporting period, and the number actually inspected.

Approved State CWD Herd Certification Program Reviews; (9 CFR 55.23(a)); (State)

APHIS may periodically review an Approved State’s CWD program. Objectives of the review include (1) evaluating program activities to verify Approved State status; (2) identifying and providing guidance on State problems in complying with Federal requirements; (3) reviewing farmed cervid surveillance activities and enrolled herd owner compliance; (4) reviewing records and documents on enrolled herds, including laboratory reports and herd inventories; as well as reviewing epidemiological reports submitted by the State-designated epidemiologist to the CWD epidemiologist and national CWD program manager; (5) assessing compliance with and completeness of data entered into the national CWD database or equivalent State database; (6) reviewing educational and outreach efforts to producers; (7) evaluating personnel and other resource needs; and (8) conducting site visits in accordance with APHIS policy.

In selecting States to review, APHIS considers States with compliance or program consistency issues, States with varying sizes of cervid industry, District balance (selecting States from each APHIS District), and review intervals (at least once every 5 years). APHIS provides to the Approved State a review report that includes the findings of the review and a request to the State to develop a response. The findings also include an action plan containing a list of recommendations or requirements to address specific issues identified and a specified period of time for completion.

Epidemiological Investigations; (9 CFR 55.23(a), (b)); (Business, State)

APHIS or State officials conduct epidemiological investigations of herds designated as CWD-suspect, trace back, or trace forward to determine if the animals in the herd were exposed to a CWD-positive animal, and the consequences of that exposure to herd status. The current Program Standards contain a worksheet that State officials may use in conducting the investigation. The results of the investigation may lead to development and implementation of a herd plan towards reinstatement of herd status or re-enrollment in the CWD Herd Certification

Program. Epidemiological investigations also may determine if the owner of the herd has not fully complied with program requirements for animal identification, animal testing, and recordkeeping, and lead to suspension of program status until a herd plan is implemented. Any herd reinstated after being placed in suspended status must comply with the requirements of the herd plan as well as the requirements of the CWD Herd Certification Program.

Appraisal, Destruction, and Payment of Indemnity (VS Form 1-23); (9 CFR 55.3, 55.5); (Business)

Cervid appraisals must be reported using VS Form 1-23. The form is completed by APHIS or a Federal employee appraiser with input from the herd owner. It is signed by both the appraiser and the owner. It lists the owner's name and address, the number of animals for which the owner is seeking payment, and the appraised value of each animal. The owner's signature on this form indicates agreement with the appraised value of each animal. The owner must also certify whether the animals are subject to a mortgage. 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. The form is scanned and emailed to the District office for approval and is kept on file in the office of the District Director.

Letter to Appeal Suspension, Cancellation, or Change in Status; (9 CFR 55.24(c)(1)); (Business)

If a herd owner's enrollment in the CWD Herd Certification Program is suspended or cancelled, or the herd’s status is lowered, the herd owner may appeal the cancellation or status reduction in writing to APHIS. This must be done within 10 days of receiving the notice of the cancellation or change in status. The appeal letter must include all of the facts and reasons on which the herd owner relies to show that the reasons for the proposed cancellation are incorrect or do not support APHIS’ action.

Interstate Certificate of Veterinary Inspection; (9 CFR 81.3, 81.4); (Business, State)

No covered cervid may move interstate unless it meets the requirements of 9 CFR 81.3. This includes, but is not limited to, cervids originating from a herd enrolled in the CWD Herd Certification Program that has reached certified status as well as imported animals and non-enrolled animals moving interstate directly to slaughter, zoo and exhibition animals from non-enrolled facilities moving interstate, and captured wild cervids moving interstate. The animals must be accompanied by a certificate completed by an accredited veterinarian that documents the origin, identity, and health status of the animal being moved. The certificate must show the official identification numbers of each animal being moved, the number of animals covered by the certificate, the purpose for which the animals are being moved, the points of origin and destination, the consignor, and the consignee. The certificate must also include a statement by the issuing accredited veterinarian that the animals were not exhibiting clinical signs associated with CWD at the time of examination. States receiving a request for import of animals into their State provide instructions of what import requirements are to be met and documents to be presented.

Wild Cervid Identification, ICVI, and Surveillance Data for Interstate Movement; (9 CFR 81.2, 81.4); (State) (Third Party Disclosure)

Each captive wild cervid must be identified with at least two forms of identification attached to the animal by the originating State. One form of identification must be official. The animal also

must be accompanied by a certificate documenting the source population to be low risk for CWD based on surveillance in that population. Summary surveillance information provided by the originating State is reviewed by APHIS and the receiving State to determine interstate movement approvals.

Inspections and Inventories, Herd Records; (9 CFR 55.23(b)); (Business, State)

Herd owners must complete annual inspections and triennial physical herd inventories for all herds enrolled in the CWD Herd Certification Program. Triennial physical inventories are conducted no more than 3 years after the last complete physical herd inventory for the herd. States must review and reconcile records of all inspections and inventories for each owner. APHIS may also participate in inspections and physical inventories activities that an owner may need to complete.

In addition, participating herd owners must maintain herd records that include complete inventories of animals stating the species, date of birth, age, and sex of each animal born into the herd; the date of acquisition and source of each animal not born into the herd; the date of disposition and destination of any animal removed from the herd; owner name, city, and State; and all individual identification numbers (from tags, tattoos, electronic implants, etc.) associated with each animal. The information must also include the name and address of the person from whom any animal was acquired or to whom it was disposed; and the cause of death, if the animal died while in the herd. The records must also state the herd’s program status and any restrictions on the herd due to disease status, as well as the date of CWD sample submission, submitter, owner, premises, and animal information, and official CWD test results from the NVSL or another approved laboratory for required samples. These written records are critical during any trace out investigation conducted by APHIS or the Approved State, and must be maintained as long as the herd remains in the program.

Chronic Wasting Disease (CWD) Inspection Report for Exemption on Testing Cervids Moved From a Herd Certification Program (HCP) Breeding Herd to a Hunting Preserve Under the Same Ownership (New); (VSG 8003.1); (Business)

APHIS allows hunt facilities to exempt from disease sampling and testing any cervids moved to the facility from a commonly owned enrolled herd (i.e., a herd owned by the same person or company that owns the hunt facility) that subsequently die. Cervids moved from an HCP herd to a hunt facility are epidemiologically linked to the origin herd and postmortem diagnostic samples collected from these cervids are representative of the health of the origin herd. Therefore, HCP-enrolled farmed cervid herd owners must conduct CWD sampling on all deaths of cervids aged twelve (12) months or older that occur on-farm, at slaughter, or at a hunt facility under the same ownership to maintain HCP status under Title 9, Code of Federal Regulations (9 CFR) Section 5.23 (b)(3). APHIS allows an exemption for hunt facilities because the Agency become aware that common hunt facility business practices often make it impractical to maintain animal inventories and to find every released animal for sampling when it dies.

The inspection report requires the date of the certified herd’s certification; the name, address, email address, and telephone number of the certified herd owner; the name, address, email address, and telephone number of the hunting facility; the locations of the respective herds (certified herd vs. hunt facility); and inventories of live animals vs. mortalities by species for the previous 3 years. A VS representative inspects the certified herd to verify that it is free of clinical

signs of CWD; animals over 12 months of age are officially identified; annual inventory numbers over the previous 3 years included all animal acquisitions, animal deaths, and animals sold or removed; that at least 8 percent of the herd was sampled annually (or if not, how that was rectified); that all on-farm mortalities and slaughtered animals over 12 months of age were sampled for CWD testing over the past 3 years; that the facility/herd owner was able to rectify any poor quality or missing sample; that all samples submitted for CWD testing from on-farm mortalities and slaughtered animals over the previous 3 years included both the obex and RPLN, along with official ID; and that laboratory records for the past 3 years were provided. If the herd passes inspection the herd owner, AVIC, and State animal health official sign the form. States return the completed form to APHIS with their annual reports to retain herd certification status.

Cooperative Agreements and Grants Workplan (New); (9 CFR 55); (State/Tribe)

APHIS received funding for an initial round of cooperative agreements in 2020 with States and Tribes to work to control the spread of CWD. APHIS currently has cooperative agreements with one Tribal entity and 24 States. The cooperative agreement is a written commitment between APHIS and the State or Tribe to cooperatively administer the program. The workplan accompanies the cooperative agreements used by States and Tribal governments. These entities complete the workplan. Information about the VS grants program can be found in the VS Grants and Agreements Program Guide.

Cooperative Agreements and Grants Financial Plan (New); (9 CFR 55); (State/Tribe)

The financial plan accompanies the cooperative agreements used by States and Tribal governments. These entities complete the financial plan. More information about this document can be found in the VS Grants and Agreements Program Guide.

Cooperative Agreement or Grant Quarterly Report (New); (9 CFR 55); (State/Tribe)

States and Tribal governments complete quarterly reports on their cooperative agreements. More information about this document can be found in the VS Grants and Agreements Program Guide.

Laboratory Disinfection Worksheet (New); (9 CFR 55.4); (Business, State)

When producers enter into a certification plan, they must agree to follow a disinfection protocol requiring use of a product registered by the U.S. Environmental Protection Agency (EPA) specifically for reduction of prion infectivity in accordance with the label or with an emergency exemption issued by the EPA for reduction of prion infectivity. On April 29, 2013, the EPA amended 40 CFR Part 152 to include prions as a “pest” under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Accordingly, only products registered with the EPA specifically for the reduction of prion infectivity can be used to disinfect premises, laboratories, and research facilities after prion exposure. Currently there are no EPA-registered products available; EPA therefore granted APHIS an exemption for the use of chlorine and sodium hydroxide (lye) in its prion control and eradication programs. The exemption requires APHIS to submit an annual report to EPA detailing the total amount of bleach and lye used by APHIS, our partners (State laboratories), and TSE-infected premises. For bleach, respondents must report the date of use, the concentration used, the amount used, and any adverse reactions noted in people, livestock, wildlife, or the environment. For lye, respondents must report the date of use, formulation (powder or liquid) used, the amount used, and any adverse reactions noted in people, livestock, wildlife or the environment.

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 has discontinued use of the VS Forms 11-1 and 11-1A because of extremely low usage.

VS Form 1-23 is initiated by APHIS with input from the herd owner and requires original signatures.

VS Forms 10-4 and 11-2 may be completed online and printed for signature. VS Form 10-4 must be submitted in hard copy with the samples, and VS Form 11-2 may be digitally signed but is usually signed in ink by State and business respondents. Both forms are available online at https://www.aphis.usda.gov/aphis/resources/forms/ct_vs_forms.

About half of the Memoranda of Understanding submitted are signed electronically. This is not a requirement.

APHIS is working to integrate the CWD annual report spreadsheet, approved/consistent State review procedures, and hunt facility testing exemption report into its Data Integration Services electronic database to allow electronic submission of annual report data. Electronic collection and submission of cervid identification information currently varies by State and is managed at the State level. Epidemiological investigations and reporting of out-of-State traces to affected States is also handled at the State level. The cooperative agreements, MOUs, and grants can also be handled electronically with verified digital signatures of State/Tribal and Federal personnel.

APHIS has specific Excel spreadsheets for completing the disinfection worksheets; these may be submitted by email or in hard copy.

Herd plans, interstate movement certificates, and appeal letters are tailored documents requiring original signatures to be valid. They are not candidates for electronic completion and signature.

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, detecting, and controlling CWD in 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 75 percent of the cervid herd owners participating in the Federal CWD Herd Certification Program are small entities. The information APHIS collects in connection with this program is the absolute minimum required to effectively operate a certification program designed to identify and track farmed cervids in the United States.

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.

Collecting this information less frequently or failing to collect it would make it impossible for APHIS to maintain its CWD Herd Certification Program, thereby hindering APHIS' ability to prevent and control the spread of CWD in the United States.

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;

Epidemiology investigation reports - APHIS requests that States provide preliminary information to APHIS within 7 business days of NVSL confirmation of a CWD-positive animal in a newly identified CWD-positive herd.

Herd owners must appeal cancellations or changes in status within 10 days of receiving notice from APHIS. This ensures the proper treatment of herds regarding their status in the CWD program and helps maintain program efficacy.

• 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;

APHIS requires herd owners to maintain their herd records for as long as the herd remains in the CWD program. This time varies from herd to herd.

• 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 other 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 publication 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 following individuals concerning the information collection activities associated with this program. It contacted these respondents by email and phone to discuss the information APHIS collects to administer its CWD herd certification and control programs. Discussed were how the Agency and the respondents 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 consulted individuals had no concerns with any of these items and had no further recommendations.

Susan Rollo, MS DVM PhD DACVPM

State Epidemiologist

Texas Animal Health Commission

Austin, TX 77023

Office: 512-719-0713

Agency Cell: 512-552-9641

[email protected]

Kevin Brightbill, DVM

State Veterinarian Director

Pennsylvania Department of Agriculture

Bureau of Animal Health and Diagnostic Services

2301 North Cameron Street

Harrisburg, PA 17110

Phone: 717-705-1626

Fax: 717-787-1868  

www.agriculture.pa.gov

Jeff Kaisand, DVM

State Veterinarian and Executive Secretary, Iowa Board of Veterinary Medicine

Iowa Department of Agriculture and Land Stewardship

Wallace State Office Building

502 E. 9^th St.

Des Moines, IA 50319

Cell: (515) 240-6632

Desk: (515) 281.0866

[email protected]

On Friday, March 5, 2021, APHIS published in the Federal Register on pages 12901 and 12902 (86 FR 12901) a 60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. Two comments from the public were received. One commenter was generally supportive of the APHIS program. The other commenter believed APHIS needed to adopt stricter CWD controls. Neither comment affected the information collection activities or the estimated burden reported in this information collection renewal request.

9. 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.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance institute, regulation, or agency policy.

No additional assurance of confidentiality is provided with this information collection. However, the confidentiality of information is protected under 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 begin to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This information collection activity asks no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

See APHIS Form 71. Burden estimates were developed from discussions with cervid herd owners, industry representatives, and State animal health authorities.

• 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 $17,365,446. APHIS arrived at this figure by multiplying the 322,546 hours of estimated burden by the estimated average hourly wage of the above respondents ($36.61), and then multiplying the product by 1.4706 to capture benefit costs.

The average hourly wage was calculated using information obtained from the U.S. DOL Bureau of Labor Statistics occupational employment statistics website http://www.bls.gov/ current/oes_stru.htm. Specific occupations include State officials (BLS USDL-21-1094, June 17, 2021, $53.68), veterinarians (SOCC 29-1131, $52.09), animal scientists (SOCC 19-1011, $35.84), ranchers and agricultural managers (SOCC 11-9013, $36.93), supervisors for agricultural workers (SOCC 45-1011, $26.16), and agricultural workers (SOCC 45-2093, $14.93).

According to DOL BLS news release USDL-21-0437 released March 18, 2021, 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 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 1). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected use full life; and (b) a total operation and maintenance and purchase of services component.

No annual cost burden is associated with capital and startup costs, operation and maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

See APHIS Form 79. The annualized cost to the Federal Government is estimated at $10,936,019.

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

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	78,128	0	215	(45,484)	0	123,397
Annual Time Burden (Hours)	322,546	0	1,935	(26,552)	0	347,163
Annual Cost Burden ($)	0	0	0	0	0	0

In this renewal request, the number of estimated respondents increased from 4,532 to 9,053. A significant number of them are for the activity Cervid Disappearances, Escapes, and Deaths; the change is attributable to an improved source of information.

There are 36 activities in this request for renewal and collectively show a decrease of 45,269 estimated responses and a decrease of 24,617 estimated hours of burden. The changes are mostly attributable to a change in source for the overall numbers, from estimates based on a National Animal Monitoring System study to data reported directly from the States with certification programs, and the addition of several new activities.

For estimate adjustments, 18 activities have 45,484 fewer estimated responses and 26,552 fewer hours of burden. Five activities reflect increased annual response estimates per respondent, adding over 8,000 hours of estimated burden. They include Interstate Certificate of Veterinary Inspection (with 2,670 additional hours), Epidemiological Investigations (state and business, 3,520 additional hours), Herd or Premises Plan (1,300 additional hours), and Sample Collection and Lab Submission (Herd Owner) (808 additional hours). Six activities reflect significant decreases in annual responses. They include Farmed/Captive Cervid ID (1,864 fewer hours); Report of Cervid Disappearances, Escapes, and Deaths (state and business) (44,000 fewer responses and 7,348 fewer hours); Interstate Certificate of Veterinary Inspection (3,180 fewer hours); Inspections and Inventories, Herd Records (state and business) (23,170 fewer hours).

11 new activities account for the discretionary changes, adding 215 estimated responses and 1,916 hours of estimated burden. They include CWD Inspection Report for Exemption on Testing Cervids Moved from an HCP Breeding Herd to a Hunting Preserve Under the Same Ownership; Cooperative Agreement; Cooperative Agreement Workplan; Cooperative Agreement Financial Plan; Cooperative Agreement Quarterly Report; and Laboratory Disinfection Worksheet. All but the first activity include both state and tribal government respondents.

One activity, Application for Chronic Wasting Disease Herd Certification Program Approval, Renewal, or Reinstatement of a State (VS Form 11-2), added a business respondent type. It was also previously titled Participation Request/Application Package. The VS Forms 11-1, 11-1A were removed due to inactivity. The net result was 1 less response and 1 less burden hour.

Four activities remained unchanged.

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

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

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be in appropriate.

VS Form 1-23 and VS Form 10-4 are used in multiple information collections; therefore, it is not 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.

The OMB expiration date will be displayed on VS Form 11-2.

18. Explain each exception to the certification statement identified in the "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

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

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