Attachment 2 - PWS Attachment Veterinary Services Memorandum No. 800.2.pdf

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Third-Party Review of the USDA's Center for Veterinary Biologics (CVB) Authorities, Regulations, and Guidance Documents
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12639526Q0102
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This is an internal memorandum from the U.S. Department of Agriculture's Veterinary Services establishing confidentiality protocols for the Veterinary Biologics Program, dated December 22, 1999.

The memorandum emphasizes that information concerning the development, preparation, and distribution of veterinary biological products obtained from licensees, permittees, or applicants is confidential and constitutes the property of those entities. Confidential information includes all submissions from veterinary biologics establishments, communications from establishment employees to Veterinary Services employees, and observations made during facility visits. Unauthorized disclosure may violate 18 U.S.C. Section 1905 and subject violators to federal penalties. The memorandum establishes four security procedures: (1) personnel must not discuss establishment activities with representatives from competing establishments or within earshot of such persons, as even procedural mentions can compromise proprietary information; (2) all submissions must be protected from unauthorized access, as visual access alone may compromise confidentiality; (3) all submitted materials must be kept under lock with information released only to authorized establishment representatives or Veterinary Services employees with legitimate need-to-know, or to other persons only with written authorization from the licensee, permittee, applicant, or Deputy Administrator, or as required by the Freedom of Information Act; and (4) all Veterinary Services employees dealing with Veterinary Biologics Program documents or establishments must receive a copy of this memorandum. This memorandum cancels the previous version dated August 2, 1984.

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December 22, 1999

VETERINARY SERVICES MEMORANDUM NO. 800.2

Subject: Confidential Information Concerning the Veterinary Biologics Program

To: Veterinary Services Management Team Directors, Center for Veterinary Biologics Area Veterinarians in Charge, VS

I. PURPOSE

This memorandum emphasizes the confidential nature of certain information concerning the Veterinary Biologics Program.

II. CANCELLATION

This memorandum cancels Veterinary Services Memorandum No. 800.2 dated August 2, 1984.

III. BACKGROUND

Much of the information concerning the development, preparation, and distribution of veterinary biological products obtained from licensees, permittees, or applicants is confidential and is the property of such licensees, permittees, or applicants. Confidential information may include anything Veterinary Services receives as a submission from a veterinary biologics establishment, anything told by a veterinary biologics establishment’s employee to a Veterinary Services employee, and anything seen during a visit to a veterinary biologics establishment. Unauthorized disclosure of confidential information may be in violation of l8 U.S.C. 1905, Public Officers and Employees, and subject to penalties specified therein.

IV. SECURITY PROCEDURES

A. Limit Discussion

Do not discuss the activities at an establishment with anyone from another establishment or within earshot of such a person. The mere mention of a procedure may be enough to provide a trained person with confidential information regarding a competitor’s establishment.

Veterinary Services Memorandum No. 800.2 2

B. Protect Submissions

Protect all submissions from unauthorized persons. A glance may be enough to provide an unauthorized person with confidential information.

C. Control Release of Information

Keep all submitted materials under lock. Release information only to an authorized representative of the establishment involved or to Veterinary Services employees who have need for the information. Release information to other persons only on written authorization from the licensee, permittee, applicant, or the Deputy Administrator or as required by the Freedom of Information Act.

D. Inform Affected Personnel

Provide a copy of this memorandum to each Veterinary Services employee who will be dealing with Veterinary Biologics Program documents or establishments.

/s/ Thomas E. Walton for

Alfonso Torres Deputy Administrator Veterinary Services

Trainee Signature:

Trainer Signature:

Justification:

Justification:

File details come from the government source that posted it. Updated .