Aphis Form 2007 - Contact And Qualifications Of Veterinary Biologics Personnel - United States Department Of Agriculture Page 2

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INSTRUCTIONS FOR COMPLETING APHIS FORM 2007

An APHIS Form 2007 (Form 2007) must be submitted for each employee who has final responsibility for USDA regulatory issues, research

and product development, product manufacturing, quality control testing, animal acquisition and use, animal disposal, and preparation of

APHIS Forms 2008. Form 2007 is also used to comply with Veterinary Services Memorandum 800.59 for the role of authorized sampler.

Please refer to Veterinary Services Memorandum 800.63 for a complete listing of positions requiring Form 2007 and additional instructions.

EMPLOYEE CONTACT INFORMATION: Print or type in each assigned block.

[A, B] Provide information for Official Correspondence.

[C] Provide current name of Licensed Establishment.

[D] Provide assigned USDA Establishment License Number.

[E] Provide telephone country code if primary work site is outside of the United States.

[F] Provide full physical address, including city and state, of primary work site.

[G] Electronic Mail is strongly encouraged for roles supported by written communication from APHIS such as; Liaison, Alternate

Liaison, Authorized Firm Representative for APHIS Form 2008 releases, and Quality Assurance/Quality Control contact.

EMPLOYEE ROLE AT ESTABLISHMENT: Roles of Liaison, Alternate Liaison, and USDA Sampler are confirmed by

Official Correspondence.

[A] List current job title(s).

[B] List employee functions or duties in the production of biologics performed at the employee’s official duty station.

[C] Provide date of Form 2007 that is to be succeeded at this Establishment, or use Checkbox to indicate a first-time submission.

3. EMPLOYEE EDUCATION: Only list education relevant to working in the biologics industry or with biological products

including viruses, serums, toxins, vaccines, allergens, antibodies, antitoxins, toxoids, immunostimulants, diagnostic components, or

analogous products. Please list the most recent education first.

[A] Provide the attended name of school, university, or institution accredited to issue degree or certification.

[B] List type of degree or certification program.

[C] Indicate date of issue on the Degree or Certificate attained. If not attained, declare most current year attended, and

the total number of years successfully completed (e.g., 2007, 3 years).

SIGNATURE OF EMPLOYEE AND DATE SIGNED: The Employee's signature confirms accuracy of the provided

information. The date this form is signed by the employee will be used as the APHIS FORM 2007 process date.

CERTIFICATION SIGNATURE: Liaison or Alternate Liaison signature is required to certify compliance of the employee, as stated.

6. APHIS USE ONLY: Do not mark in this section; reserved for APHIS processing.

PRIVACY ACT NOTICE

The information requested on this form will not be retrieved from our files by using your name or personal identifier and is, therefore, in the opinion of this

agency, not subject to provisions of the Privacy Act of 1974. However, in keeping with the spirit and intent of the Privacy Act, we are informing you of the

following:

Authority:

9 CFR, Section 114.7

Purpose:

That compliance with the Act and applicable regulations be under supervision of person(s) competent in the preparation of biological

products.

To determine that the responsible person(s) producing biological products is qualified by training and experience and demonstrates fitness

Routine uses:

to produce such products in compliance with the Act.