0579-0254

SUPPORTING STATEMENT – 0579-0254

Inspection, Licensing, and Procurement of Animals

Justification April 2007

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 Laboratory Animal Welfare Act (AWA) (Public Law 89-544) enacted August 24, 1966, and amended December 24, 1970 (Public Law 91-579); April 22, 1976 (Public Law 94-279); and December 23, 1985 (Public Law 99-198) requires the U.S. Department of Agriculture (USDA) to regulate the humane care and handling of most warm-blooded animals used for research or exhibition purposes, sold as pets, or transported in commerce. This legislation and its amendments were the result of extensive demand by organized animal welfare groups and private citizens requesting a Federal law to protect such animals.

USDA, Animal and Plant Health Inspection Service, (APHIS) Animal Care (AC), has the responsibility to enforce the AWA and the provisions of 9 CFR, Chapter 1, and Subchapter A, which implements the AWA.

The stated purpose of the AWA, Section 1(b), includes the following:

"... (1) To insure that animals intended for use in research facilities or exhibition purposes or for use as pets are provided humane care and treatment;

(2) To assure the humane treatment of animals during transportation in commerce; and

(3) To protect the owners of animals from the theft of their animals by preventing the sale or use of animals which have been stolen..."

Section 21 of the Act authorizes the Secretary to promulgate such rules, regulations, and orders as he/she may deem necessary in order to effectuate the purposes of the Act.

Sections 10, 11, 12, and 13 of the AWA authorize and require certain recordkeeping requirements for regulated facilities. Title 9 CFR Subchapter A, Part 2 stipulates certain conditions, including recordkeeping, for licensure or registration under the AWA, as well as certain conditions that must be documented in order for dealers, exhibitors, research facilities, etc., to hold, buy, sell and/or ship animals. Records of these conditions and their use must be kept for a period of at least 1 year. These records are necessary for APHIS to review and ensure that the licensees and registrants have met all licensing and registration documentation requirements and that the animals are acquired in the prescribed manner that is required by the regulations.

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.

The records and reports herein provide APHIS with the data necessary for the review and evaluation of program compliance by regulated facilities, and provide a workable enforcement system to carry out the requirements of the AWA, and the intent of Congress, on a practical daily basis without resorting to more detailed and stringent regulations and standards which could be more burdensome to regulated facilities.

Sections 2.1(a) (1) and 2.2(a) - These sections provide for the application for licensure and acknowledgment of receipt of the regulations and standards by signing the application form before the license is issued, and applies to any person operating or desiring to operate as a dealer, exhibitor, or operator of an auction sale, except as exempted under Section 2.1(a) (3). The application form must be filed in the Regional office, and include a valid mailing address, a valid premise address, and acknowledgment of receipt of the regulations and standards.

Section 2.3 - This section provides for the request for additional pre-licensing inspections if the requestor did not pass on the first inspection. There is no set method for making such a request, although it may be made in writing.

Sections 2.132 (d), 2.35 - These sections provide for the recordkeeping requirements for obtaining dogs, cats, and other animals by dealers or research institutions. Among the records required are the name and address of the person supplying the animals; the identification of the animals, including a description, gender, age, identification number or tattoo, date of transaction, and, where required, health certificate. In addition, the licensee must also obtain a certifying statement from any unlicensed source indicating the validity of and reason for the exemption from licensure under which they are operating. The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS 7001), Record of Acquisition and Dogs and Cats on Hand (APHIS Form 7005), and Record of Disposition of Dogs and Cats (APHIS 7006) are forms which may be used by research facilities to keep and maintain the information required by the AWA. Other methods of maintaining the records are allowed as long as the above information is retained and APHIS has access to the records. All records and reports must be maintained for at least 3 years.

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 APHIS 7001 form is a multi-part form that requires original signatures and must accompany shipments of animals. The APHIS 7005 and 7006 are downloadable from the web for recordkeeping (www.aphis.usda.gov/library/forms or www.aphis.usda.gov/ac ). APHIS 7005 is kept on the premises of the dealer or research facility, and APHIS 7006 is kept on the premises and a copy must accompany the animals in transport.

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.

APHIS is the only Agency charged with the enforcement of the AWA; therefore, there is no duplication of reporting by other Federal agencies. There are no permanent identification requirements under the Endangered Species Act, so there is no duplication of effort in identifying these animals.

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

The information APHIS is collecting for this program will minimize the burden on those who are to respond through the use of automated, electronic, mechanical, and other collection technologies that will permit electronic submission of responses.

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.

The information collected is the minimum required to ensure that the AWA is being enforced. Without these records, investigations and proceedings against violators would be impossible. These records are structured to minimize the reporting burden and yet meet provisions of the AWA. If this information collection were not conducted, or conducted less frequently, it would impair the effective enforcement of the AWA by APHIS.

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.

No special circumstances exist that would require this collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and 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.

Individual consultation and contact during 2006 - 2007 include the following:

Ms. Mimi Brody

HSUS

2100 L Street, NW

Washington, DC 20037

(301) 258-3123

Ms. Jayne Mackta

New Jersey Association for Biomedical Research

1477 Morris Avenue

Union, New Jersey 07083

(908) 964-9449

Mr. Marshall Meyers

Pet Industry Joint Advisory Council

Suite 400

1220 19th Street, N.W.

Washington, DC 20036

(202) 452-1525

On Friday, February 16, 2007, pages 7595 -7596, 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.

There are no payments or gifts to any respondents.

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

There is no confidentiality assured for the application, renewal application, or certification statement.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

There are no questions of a sensitive nature asked of the respondents.

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.

A total of 41 burden hours are needed to complete this information collection activity. The estimates were developed from historical data, AC’s Licensing and Renewal Information System, calculated average number of certificates, and from discussions with field personnel. See APHIS Form 71 for hour burden estimates.

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.

There are no additional cost burdens to the respondents or recordkeepers.

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 estimated cost for the Federal Government is $ 354.10 (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.

There is a difference of -6 total burden hours from the last collection. This reduction resulted from a decrease in the number of respondents completing applications and licensees.

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

APHIS has no plans to tabulate or publish this information collection.

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.

If the forms were to be discarded because of an outdated OMB expiration date, but were otherwise usable, it would result in higher printing costs to the Federal Government. Therefore, APHIS is seeking approval to not display the OMB expiration date on its forms.

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

APHIS certifies compliance with all provisions of the Act.

B. Collections of Information Employing Statistical Methods

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