2017 SS 0245 new

SUPPORTING STATEMENT 0579-0245

HIGHLY PATHOGENIC AVIAN INFLUENZA, ALL SUBTYPES, AND NEWCASTLE DISEASES; ADDITIONAL RESTRICTIONS

2017

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002.

The U.S. Department of Agriculture (USDA) is responsible for preventing the introduction or dissemination of contagious or communicable diseases of animals (including birds and poultry from a foreign country) into the United States, or from one State to another. USDA’s Animal and Plant Health Inspection Service (APHIS), through its Veterinary Services (VS) program, carries out this disease prevention mission. VS regulations for preventing the introduction of foreign animal diseases into the United States are contained in title 9, Code of Federal Regulations, subchapter D, Exportation and Importation of Animals (Including Poultry) and Animal Products. Parts 93, 94, 95, and 96 of this subchapter govern the importation of certain live animals, birds, and poultry (including hatching eggs); and meat, other animal products and byproducts, hay, and straw into the United States to prevent the introduction of various animal diseases.

Highly pathogenic avian influenza (HPAI) is an extremely infectious and often fatal viral disease affecting all types of birds and poultry. HPAI can strike poultry quickly, without infection warning signs. Once established, the disease can spread rapidly from flock to flock. This form of influenza, when caused by certain viral subtypes such as H5N1, can also adversely affect humans and other animals, such as pigs. The regulations at 9 CFR 94.6 concern carcasses, meat, or products of carcasses of poultry from regions where HPAI or Newcastle disease (ND) is considered to exist.

Regulations at 9 CFR 94.6(c) deal specifically with the importation of eggs (other than hatching eggs) from certain regions that may pose a risk of introducing HPAI or ND into the United States. Like HPAI, ND is an extremely infectious and often fatal viral disease of birds and poultry. ND does not currently exist in birds or poultry in the United States, but can strike quickly. Infection and mortality can reach 100 percent of a given population of birds or poultry. Once established, either disease can spread rapidly from flock to flock in commercial poultry. Although 9 CFR 94.6(c) applies to any region where ND is considered to exist, the United States is not currently importing eggs from any ND-affected region.

APHIS’ efforts to continue to effectively prevent the introduction of foreign animal diseases of poultry into the United States require the use of information collection activities as described below. APHIS is asking the Office of Management and Budget (OMB) to approve its use of these information collection activities for 3 years.

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 collection activities to continue to effectively prevent the introduction of foreign animal diseases of poultry, such as HPAI and ND, into the United States.

Application for Permit to Import Controlled Material; Import or Transport Organisms or Vectors (specifically bird carcasses or parts of carcasses) (VS Form 16-3)

(Individuals, Business, and Not for Profit) – 9 CFR 94.6(b)

Carcasses or parts or products of poultry (including feathers, nests, and trophies, which are all covered under part 95), game birds, and other birds from regions where ND or HPAI are considered to exist, and that do not otherwise qualify for importation, may be imported only if the U.S. importer, using the VS 16-3, applies to APHIS and is granted a permit authorizing such importation. Permission will be given only when APHIS determines that the importation will not risk introduction or dissemination of ND or HPAI into the United States. Application for a permit may be made in accordance with the regulations contained in 9 CFR 94.6. The VS Form 16-3 is available on the APHIS Web site.

This permit application contains the importer’s name, address, telephone number, fax number, and email address; the name and address of the exporter of the material or product; a description of the products to be imported; the quantity and frequency of importation; the mode of transportation; the proposed use of the material; a description of the applicant’s facilities for handling the material; the qualifications of the technical personnel who will be working with the materials; and a description of any processing the material may have undergone before importation into the United States.

This information enables APHIS to carefully scrutinize the products and determine what, if any, disease threat they may pose to the U.S. poultry population. If APHIS decides to issue an import permit, information on the VS 16-3 also enables APHIS to determine what safeguards are appropriate for this particular importation. APHIS can then provide port and border personnel with appropriate clearance instructions for the impending shipment.

Import Permit for Controlled Materials or Transport Organisms and Vectors (VS Form 16-6A)

(Individuals, Business, and Not for Profit) – 9 CFR 94.6(b)

If an importer fills out the VS 16-3 application and VS determines that a shipment qualifies for import, VS will issue the importer an import permit, VS Form 16-6A, which is done electronically.

Application for Approval or Report of Inspection Establishment Handling Restricted Animal Byproducts or Controlled Materials (VS Form 16-25) (Business) – 9 CFR 94.6(b)

An establishment must provide evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect restricted animal byproducts or controlled materials so as to prevent the introduction or dissemination of ND and HPAI. This evidence is provided on VS Form 16-25. The following information is requested: date of last inspection, agreement expiration date (if applicable), method of transportation by which products are received, countries from which products originate, approximate yearly volume, name and title of contact person for the establishment, byproducts or materials handled at the establishment, method of sewage disposal, capacity and construction material of separate storage facilities (if applicable), whether there is adequate separation of restricted and unrestricted materials, the method of transportation by which products are moved to the storage facility, method of transportation by which products are moved to the processing area, detailed description of how restricted materials are processed and/or disinfected, name of the supervisor of processing and disinfection, name of disinfectants used, and the methods used to disinfect containers. The signature of the inspector, the District Director, and the approving official (Staff Veterinarian for Import-Export) are also required.

Agreement for Handling Restricted Imports of Animal Byproducts and Controlled Materials (VS Form 16-26) (Individuals and Business) – 9 CFR 94.6(b)

Restricted animal products, byproducts, and controlled materials including carcasses (or parts or products of carcasses) of poultry, game birds, and other birds may be imported for consignment to any museum, educational institution, or other establishment that has given APHIS evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the introduction or dissemination of ND and HPAI. Establishments that APHIS determines meet the criteria are eligible to enter into an agreement for handling restricted imports of animal byproducts and controlled materials via VS Form 16-26. The form requires signatures from the establishment officer, the District Director, and a Staff Veterinarian for Import-Export.

Report of Entry, Shipment of Restricted Imported Animal Products and Animal Byproducts and Other Material (VS Form 16-78) (Individuals, Business, and Not for Profit) - 9 CFR 94.6(b)

This form accompanies all restricted animal products moving from the port of entry to APHIS-approved establishments or APHIS-approved storage facilities. Part A of this form is completed by U.S. Government inspectors at the port of entry. Part B of this form is completed by approved establishments; that is, museums, educational institutions, or other establishments approved to receive bird or poultry carcasses or products for educational purposes. The establishments forward a copy of this form to the VS District Office. The completed form helps APHIS ensure that the imported restricted materials are stored and processed in accordance with the requirements of 9 CFR 94.6.

Establishments must provide the following information on VS Form 16-78: Date products or materials are received; the name of the approved establishment; whether the shipment is intact (if not an explanation must be given); date of treatment completion; whether the railroad car, truck, or other mode of transport has been disinfected; disinfectant used; method of treatment; disposition of refuse; and the name and signature of the establishment owner.

Application of Seals to Shipping Containers (Foreign Government) – 9 CFR 94.6(b)(5)(i)

Carcasses, and parts or products of carcasses (including meat) of poultry, game birds, or other birds, that originated in a region considered to be free of ND and any subtype of HPAI, and that are processed in a region where ND or HPAI is considered to exist, must be in closed containers sealed with serially numbered seals applied by an official of the national government when they are shipped from either region. On inspection at the port of entry, U.S. Government inspectors ensure that the seals are in place and unbroken. There are no documents associated with this task.

Recordkeeping by Processing Establishments (Foreign Government) – 9 CFR 94.6(b)(5)(II)(B)

When products originating from a region considered to be free of ND and any subtype of HPAI are processed in a region where ND or HPAI is considered to exist, the processing establishments must keep required records on file, including certificates, at the facility for at least 2 years after exporting processed products to the United States. These records need to be available when USDA inspects the establishments to help ensure that the establishments meet all USDA requirements.

Cooperative Service Agreements (Business)– 9 CFR 94.6(b)(iii)

Operators of processing establishments must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS in inspecting the establishment. The agreement is valid for 5 years.

Application for Import Permit (VS Form 17-129)

(Individuals and Business) - 9 CFR 93.103(a), .9 CFR 93.201

Birds, poultry, and hatching eggs imported to the United States from any region, except for pet birds returning from Canada via a land border port, must be accompanied by an APHIS-issued import permit. The owner of the avian shipment can obtain this permit by completing a permit application, VS Form 17-129, which is available on the APHIS Web site.

The application asks for the name and address of the shipper in the country of origin; the port of embarkation and entry; mode of transportation used; the name, address, and phone number of the importer; the number, breed, species, and description (sex, age, registered name and number, tattoo, tag number, other markings) of the animals imported; the purpose of importation; the route of travel; the proposed shipping date; the proposed arrival date; the name and address of the person to whom delivery will be made; and where the delivery will be made in the United States.

This information allows APHIS to determine the level of risk associated with the shipment and the appropriate risk-mitigating measures to take, if necessary, to ensure the shipment poses a minimal risk of introducing HPAI and ND into the United States.

Notarized Declaration or Affirmation (Individuals) – 9 CFR 93.101, .201(c)(iii)(A)

In addition to VS Form 17-129, pet birds, performing birds, and theatrical poultry returning to the United States must be accompanied by a notarized declaration, affirmation, or statement signed by the owner and witnessed by a USDA inspector that states that the birds or poultry were not in contact with other birds or poultry while out of the United States. The information requested provides APHIS with another means of ensuring that U.S. origin pet birds, performing birds, and theatrical poultry returning to the United States were not exposed to avian populations of unknown health status.

Agreement of Pet Bird Owner (VS Form 17-8) (Individuals) – 9 CFR 93.101,

9 CFR.201(c)(2)(iii)(B)

Owners of U.S.-origin pet birds, non- U.S. origin pet birds, performing birds, or theatrical poultry must sign a pet bird agreement at the first U.S. port of entry at the time of import. This form documents the importation of these categories of birds, noncompliance and rejection of import, the surrender of birds to Federal authority (if the owner chooses to abandon the bird on import) and receipt of a pet bird, performing bird, or performing poultry into home or Federal quarantine. The form is the tool used to inform the importer or owner of the commitment to impose a 30-day home quarantine. The form is also used to allow the APHIS port veterinarian to place the bird into Federal quarantine for 30 days from the time of arrival at the first port of U.S. entry. Owners can obtain this agreement from a Federal inspector at the U.S. port of entry or from the APHIS Web site.

This agreement requires the following information: The owner's name, address, and phone number; the number and kind of birds or poultry the owner is importing into the United States; information on the route of travel; and the date the birds are offered for entry. The form has four sections; depending on which situation applies, the importer or owner will complete different sections. Section A refers to U.S.-origin pet birds, performing birds, and performing poultry and home quarantine situations and requires: Location where the bird will be held in quarantine, name and address of local Federal contact, laboratory specimens taken at the port of entry, and signature of owner. Section B refers to non-U.S. origin pet birds, performing birds, and performing poultry. The owner must certify that the birds have been in his or her possession for at least 90 days before importation and they are apparently healthy. This form accompanies the bird into Federal quarantine. Section C requires a signature only from the importer and states noncompliance and a rejection of import. Section D refers to abandonment of the bird due to noncompliance and, by owner signature, allows disposal of the bird or poultry.

Notification of Signs of Disease in a Recently Imported Bird Allowed to Enter Home Quarantine

(Individuals) – 9 CFR 93.101, .9 CFR 201(c)(2)(iii)(B)(2)

Owners of U.S.-origin pet birds, performing birds, or theatrical poultry imported to a home quarantine must immediately alert Federal officials if the owners note signs of disease during home quarantine. To do this, owners call their local VS District Offices and inform office staff of the bird’s signs of disease. This call should last 5 minutes or less. The District Office then sends out a Federal accredited veterinarian to assess the bird’s condition. This is an informal process involving a small number of respondents.

Certificate for Eggs from ND Regions (Foreign Government and Business) – 9 CFR 94.6(c)(1)

Imported eggs (other than hatching eggs) from poultry, game birds, or other birds from ND-affected regions must be accompanied by a certificate completed and signed by a salaried veterinary officer of the national government of the region of origin or, if from Mexico, by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico. The endorsement indicates that the veterinarian was authorized to issue the certificate.

The salaried veterinary officer of the national government of the region of origin must identify on the certificate the flock of origin, the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs (and cases of eggs) shipped with the certificate, and the date the certificate was signed. The eggs qualify for importation in accordance with 9 CFR 94.6(c) if, no more than 90 days before the certificate was signed, a salaried veterinarian accredited by the national government inspected the flock of origin and found no evidence of communicable diseases of poultry; no ND occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed; there is no evidence that the flock of origin was exposed to ND during the 90 days before the certificate was signed; the eggs are from a flock of origin found free of ND; and egg drop syndrome (EDS) is notifiable in the region of origin and there have been no reports of EDS in the flocks of origin of the eggs, or within a 50-kilometer radius of the flock of origin, for the 90 days before issuance of the certificate.

Government Seals (Foreign Government) – 9 CFR 94.6(c)(1)(i)

Before leaving the premises of origin, the cases in which the eggs are packed must be sealed with the seal of the national government by the accredited veterinarian who signed the certificate. The seal is documented on the egg certificate and requires no other paperwork.

Veterinary Health Certificate (Foreign Government) – 9 CFR 93.104

All pet birds, all research birds, and all commercial and zoological birds offered for importation from any part of the world shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the exporting region or issued by a veterinarian authorized or accredited by the national government or the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region. The certificate must state:

• That all birds covered by the certificate have been inspected by the veterinarian issuing the certificate;

• That no evidence of Newcastle disease, HPAI, chlamydiosis, or other communicable disease of poultry was found among the birds;

• That the birds were not exposed to ND, HPAI, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding their exportation;

• That the birds have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza;

• That HPAI or ND did not occur anywhere on the premises from which the birds were to be exported or on adjacent premises during the 90 days immediately preceding the exportation of the birds;

• That neither the premises from which the birds were to be exported nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the birds, and that the birds have not originated from or been moved through a region identified in accordance with 9 CFR 94.6(a) of this subchapter as a region where highly pathogenic avian influenza exists;

• That the birds were placed into new or appropriately sanitized packaging materials at the premises from which the birds were to be exported.

The certificate should also show the number from the leg band, tattoo, or microchip affixed to the birds prior to departure. During port of entry veterinary inspection it must be determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate.

Notice of Arrival – Live Animals (Business)

Import permits generated in response to receipt of Forms 17-129 must accompany the shipment of live animals at the time of their arrival into the United States. To ensure the availability of a VS port veterinarian, the date, time, and (if applicable) flight schedule of the incoming shipment must be confirmed to the veterinarian at the port of entry listed on the permit at least 3 business days before presentation. The notification must include the times and dates of arrival in the United States; the times and dates of exportation from the United States; the mode of transportation; and serial numbers on any sealed containers.

Further, the importer/permittee (or his or her designated agent) must contact APHIS at least 3 business days in advance of the shipment at all locations involving additional services (i.e., quarantine) listed in the permit to arrange for payment. Failure to make adequate arrangements may cause delays or prevent further movements of shipments into or through the United States.

Notice of Transfer – Animal Products (Business) - (9 CFR 94.15)

In general, APHIS does not require notice of arrival for animal products. However, 9 CFR 94.15(e) specifies that any meat or other animal product not otherwise eligible for entry into the United States may transit the United States for immediate export if the importer notifies the APHIS officer at the U.S. port of arrival of the transiting of such meat or other animal product prior to such transiting; such transit is limited to the maritime or airport port of arrival only, with no overland movement outside the airport terminal area or dock area of the maritime port; and the meat or other animal product is not held or stored for more than 72 hours at the maritime or airport port of arrival.

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.

The VS 16-3 is available to the public electronically at: http://www.aphis.usda.gov/forms/vs16-3.pdf or at http://www.aphis.usda.gov/animal_health/permits/downloads/vs16_3.pdf.

Respondents can submit the VS 16-3 electronically through the e-Permits system, which requires E-authentication. Respondents can apply for E-authentication at http://www.eauth.egov.usda.gov/ and access E-permits at https://epermits.aphis.usda.gov/epermits.

However, some importers may not choose to become e-Authenticated. Those importers must submit the VS 16-3 by fax or mail.

The VS 16-6A can be prepared electronically through the ePermits system at https://epermits.aphis.usda.gov/epermits and emailed to the importer.

The VS 16-25 is obtained from the VS District Office. The form requires original signatures and cannot currently be submitted electronically. However, APHIS continues to work to make the form available for submission via its Veterinary Services Processes Streamlining system.

The VS 16-26 requires an original signature and therefore is not a candidate for electronic submission at this time. However, APHIS continues to work to make the form available for submission via its Veterinary Services Processes Streamlining system. This system is currently used at headquarters and APHIS is working to extend its availability to the field.

The VS 16-78 is obtained from the Customs and Border Patrol inspector with the Government-wide utilization of the International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to improve business operations and further Agency missions.  This will allow respondents to submit the data required by U.S. Customs and Border Protection and its Partner Government Agencies (PGAs), such as APHIS  to import and export cargo through a Single Window concept.

VS Form 17-129 is available to the public electronically at www.aphis.usda.gov/import_export/forms.shtml and can be submitted by fax or mail. The application can be submitted through the e-Permits system found at: http://www.aphis.usda.gov/permits/login_epermits.shtml The permit generated as a result of the Form 17-129 must accompany the shipment.

VS Form 17-8 is available to the public electronically at www.aphis.usda.gov/import_export/forms.shtml. However, it is not completed until the time of arrival in conjunction with the port inspection. Data from the VS 17-8 is electronically submitted by Federal inspectors at the U.S. port of entry. To be valid, it requires original signatures from the pet bird owner, the detaining official, the releasing official, and the final releasing official. It is therefore not a candidate for electronic submission.

If an owner notifies a VS District Office regarding signs of disease in a recently imported bird, he or she does so by phone. This notification can occur via email, but importers are encouraged to notify the District Office directly of signs of disease by calling. There is no form involved.

The Certificate for Eggs and the Health Certificate must physically accompany the shipment, and require original signatures from the authorizing veterinarian to be valid. The certificates are therefore not candidates for electronic submission.

The seals also physically accompany the shipment and thus are not candidates for electronic submission.

Notices of arrival and transfer are generally made by telephone.

APHIS is involved with the Government-wide utilization of the International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to improve business operations and further Agency missions.  This will allow respondents to submit the data required by U.S. Customs and Border Protection and its Partner Government Agencies (PGAs), through a Single Window concept.  APHIS is also establishing a system known as e-File for CARPOL (Certification, Accreditation, Registration, Permitting, and Other Licensing) activities.  This new system will strive to automate some of these information collection activities.  The system is still being developed and business processes continue to be identified and mapped.

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 detecting and controlling contagious animal diseases in the United States.

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

The information APHIS will collect in connection with this program is the minimum needed to protect U.S. birds and poultry from the introduction of ND and HPAI. Approximately 17 percent of the respondents in this information collection are considered small entities.

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 establish an effective line of defense against introduction of ND and HPAI. The introduction and spread of these diseases within the United States could have serious economic consequences for the domestic poultry industry.

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;

Notification of Signs of Disease in a Recently Imported Bird Allowed to Enter Home Quarantine -Owners of U.S.-origin pet birds, performing birds, or theatrical poultry imported to a home quarantine must immediately alert Federal officials if the owners note signs of disease during home quarantine. To do this, owners call their local VS District Offices and inform office staff of the bird’s signs of disease.

• requiring respondents to submit more than an original and two copies of any document;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than 3 years;

• in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

No 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 recordkeeping, 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 has engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Mr. Jamie McKee – Poultry Hatching Eggs

Export & Sales Compliance Manager

Aviagen Turkeys Inc.

31186 Midland Trail East

Lewisburg, WV 24901

Phone: 304-793-2680 ex.228

Fax: 304-793-2684

Email: Jamie [email protected]

Ms. Anna Melino – Commercial Birds

Rare Zoo Imports

UNIT 1 P PTY 6566

2250 NW 114th Ave.

Miami, FL 33192-4177

Phone: 438-338-1054 or 514-570-1283

Email: [email protected]

Mr. Andrew Harrop – Day Old Chicks

Branch Manager

DSV Air & Sea Inc.

333 N. Sam Houston Parkway East, Suite 725

Houston TX 77060

Phone: 281-590-5590 ex 2803

Cell Phone: 817-703-9564

Fax: 281-590-5511

Email: [email protected]

On Monday, January 23, 2017, pages 7789-7790, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. No comments from the public were received.

9. Explain any decision to provide any payment or gift to respondents, other than reenumeration of contractors or grantees.

Per the cooperative service agreement there is a pay for the costs associated with inspections.

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-I.

See APHIS Form 71. Burden estimates were developed from U.S. importers, owners, or operators of establishments that handle restricted or controlled materials, and foreign 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 $67,374.78. APHIS arrived at this figure by multiplying the hours of estimated response time (2,046) by the estimated average hourly wage of the respondents ($32.93). The hourly rates of private industry workers and health-related professional specialists are from the U.S. Department of Labor; Bureau of Labor Statistics May 2015 Report - Occupational Employment and Wages in the United States. See http://www.bls.gov/news.release/ocwage.t01.htm . APHIS determined that the hourly wage for foreign animal authorities would be comparable to the wage for U.S. health related professionals.

Farmers, ranchers, and other agricultural managers - $34.89

Buyers and purchasing agents, farm products - $29.02

Animal scientists - $34.90

13. Provide estimates of the total annual cost burden to respondents or recordkeepers resulting from the collection of information (do not include the cost of any hour burden shown in items 12 and 14). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

Per the cooperative service agreement there is a pay for the costs associated with inspections. There is also a processing cost associated with the use of the ePermits system.

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.

The annualized cost to the Federal Government is estimated at $59,088. (See APHIS Form 79.)

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

ICR Summary of Burden:

	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	3,707	0	894	944	0	1,869
Annual Time Burden (Hr)	2,046	0	730	261	0	1,055
Annual Cost Burden ($)	0	0	0	0	0	0

There is a program increase of +894 responses resulting in an increase of +730 total burden hours. This increase is due to the addition of the following activities being added to this information collection which were omitted from the previous submission and is be being counted as a violation by APHIS: (1) Certificate for Table Eggs, (2) Government Seals, (3) Veterinary Health Certificate, (4) Notice of Arrival, and (5) Notice of Transfer.

There is an adjustment of decrease of -707 respondents; however, there is an increase of +944 responses and +261 total burden hour. The adjustments are due to more countries being considered to be affected with HPAI (and consequently more findings and more reports of the disease), the number of approved establishments increasing as more taxidermists apply for approval, and general adjustments in the amount of paperwork received.

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 inappropriate.

VS 16-3, VS 16-25, VS 16-26, VS 17-8, and VS 17-129 are used in multiple information collections; therefore, it is not practical to include OMB expiration dates because of the various expiration dates for each collection. APHIS is seeking approval to not display OMB expiration dates on these forms.

APHIS will display expiration dates on the VS 16-6A and 16-78 Forms.

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

APHIS can certify compliance with all 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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