APHIS Form 2007 Contact and Qualifications of Veterinary Biologics Perso

Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124

APHIS 2007 (Apr 2015)(Secured)

Virus-Serum-Toxin Act and Regulations - Business

OMB: 0579-0013

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UNITED STATES DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES
CENTER FOR VETERINARY BIOLOGICS

CONTACT AND QUALIFICATIONS
OF VETERINARY BIOLOGICS PERSONNEL
1. EMPLOYEE CONTACT INFORMATION
[A] TITLE

(Dr., Mr., Ms.)

OMB Approved
0579-0013
EXP: XX/XXXX

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information is
0579-0013. The time required to complete this information collection is estimated to average 0.2 hours per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information.

(Print information in area requested.)

[B] LAST NAME, (include applicable suffix)

[D] ESTABLISHMENT
LICENSE NUMBER

This report is required by regulations (9 CFR 102.4 and 114.7). Failure to report can result in suspension or
revocation of establishment license.
(See instructions on reverse side for additional instructions)

FIRST NAME

MIDDLE [C] ESTABLISHMENT NAME
INITIAL

[E] TELEPHONE NUMBER

[F] ADDRESS OF YOUR PRIMARY WORK SITE

[G] EMAIL (Recommended)

2. EMPLOYEE ROLE AT ESTABLISHMENT

(use additional lines, if necessary.)

[A] TITLE OF POSITION HELD

[C]
DATE OF PREVIOUS
APHIS FORM 2007 ON
FILE FOR EMPLOYEE
(mm/dd/yyyy)

[B] FUNCTION(S) OR DUTIES

☐

NEW FORM 2007

CHECK THIS BOX IF THERE IS
NO PREVIOUS FORM 2007 ON
FILE FOR EMPLOYEE
AT THIS ESTABLISHMENT.

3. EMPLOYEE EDUCATION
[A] NAME OF SCHOOL, UNIVERSITY OR INSTITUTION

SIGNATURE IN BLOCK 5.
CERTIFIES SUBMITTED FORM
(See Privacy Act Notice at bottom of instructions.)

[B] TYPE OF DEGREE OR CERTIFICATION

4. SIGNATURE OF EMPLOYEE AND DATE SIGNED (mm/dd/yyyy)

--------------------------------------------------------------------------------------DATE-----------------------------

5. [A] CERTIFICATION SIGNATURE (Liaison or Alternate Liaison)
I certify that this person is competent by training, education, and experience, and has demonstrated
fitness abilities as listed, in the Functions Block 2., to produce such products in compliance with the
Act.
----------------------------------------------------------------------------------------------------------------------------------6. APHIS USE ONLY: Receipt Identification Block

APHIS FORM 2007
APR 2015

[C] DATE ATTAINED (mm/dd/yyyy)

[B] SIGNATORY TITLE

☐
☐

[C] DATE CERTIFIED
(mm/dd/yyyy)

LIAISON

ALTERNATE LIAISON

DATE CONTROL AREA

(Previous editions are obsolete.)

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.
1.

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.

2.

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).
4.

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.

5.

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.

Routine uses:

To determine that the responsible person(s) producing biological products is qualified by training and experience and demonstrates fitness
to produce such products in compliance with the Act.


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