Title: Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection and Compliance
Release Date: 21 May 2021 | Document Number: CVB-SOP-0045.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0045.02
Page 4 of 4
5.3 Filing:
All Form 2007s are either received through the NCAH Portal and the official
record is kept with the Mail log, or if it is received hard copy, then it is scanned
and that record becomes the official file.
5.4 Retention:
Obsolete Form 2007 information has a retention time of 10 years after the
termination of the entity or individual.
Correspondence relating to personnel or Form 2007s should be retained as long as
the referenced Form 2007 is still active.

6. References

6.1 Title 9, Code of Federal Regulations, part 114, section 7, Personnel at Licensed
Establishments, current version

6.2. _- Veterinary Services Memorandum No. 800.63, Personnel at Licensed
Establishments
7. Summary of Revisions
Version CVB-SOP-0045.02
e Updated document numbers through the document
¢ Document number has changed from ICSOP0035 to CVB-SOP-0045.
Version ICSOP0035.03
e The Contact information has been updated.
e Removed all procedures as these have been incorporated into work instructions.
e¢ Removed the IC-OAA duties.
Version ICSOP0035.02
e The Contact information has been updated.

e Information pertaining to the NCAH Portal role access has been added

mn 26 May 2021, 10:17:02 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Release Date: 21 May 2021

Title: Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection and Compliance
a Document Number: CVB-SOP-0045.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0045.02
Page 3 of 4

2.4 Specialist: Biologics Specialist

2.5 Form 2007: APHIS Form 2007 — The official form submitted by biologics
manufacturers to file the biographical summaries of the regulatory
Liaison and all persons responsible for any phase of preparation or
initial distribution of a biological product.

2.6 LSRTIS: Licensing, Serial Release, and Testing Information System. This
database system is the information management system used by the
CVB for serial information and processing.

Responsibilities

41 CVB-PEL: CVB-IC receives all Form 2007s, new and revised. Form 2007s for
an addition, change, or deletion of the Liaison or Alternate Liaison is forwarded to CVB-
PEL in accordance with the current version of CVB-WI-0086, Receiving and Updating
Establishment Personnel Data.

4.2 BCA: The BCA performs a preliminary review of the Form 2007 and enters the
data from the Form 2007 into LSRTIS or updates an existing record. The BCA also
forwards the Form 2007s to the Specialist for review and finalizes any required
correspondence back to the firm.

4.3. Specialist: The Specialist reviews the Form 2007s and associated
correspondence. Once completed, the documents are returned to the appropriate BCA.
The Specialist authorizes government sampler when requested by the manufacturer.

Procedures

5.1 Follow CVB-WI-0086 for workflow procedures in Receiving and Updating
Establishment Personnel Data for both LSRTIS — Establishment Employees and
Mail Log entry.

5.1.1 Access to NCAH Portal is determined by roles. See the NCAH Portal User
Guide 2, NCAH Portal Roles and Privileges.

5.2. Newly licensed Firms:
Assurances that the establishment and addresses (sites) are entered properly into
LSRTIS must be conducted. This information initiates the ability to enter site
information for an establishment employee record.

New firms may need to have NCAH Portal access provided. Follow procedures
on the CVB Website for guidance:
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-

biologics/sa_ncah_portal_guidance/ct_vb_ncah_portal_access

a: 26 May 2021, 10:17:02 am.
Controlled by: ter tor Veterinary Biologics, 515-337-6100


Title: Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection and Compliance
Release Date: 21 May 2021 ce Document Number: CVB-SOP-0045.02

USDA
a7

Animal and Plant

Health Inspection Processing of the APHIS Form 2007 by the Center for Veterinary
Veterinary Services  Biologics-Inspection and Compliance

Center for Veterinary
Biologics

CONTROLLED//PROPIN//BASIC

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(515) 337-6100

Document Number: CVB-SOP-0045 Revision: 02
Previous Number: ICSOP0035.03

Vault: CVB-Released

Section/Area: CVB-SOP-IC

Effective Date: 21 May 2021

Notes:

a. 26 May 2021, 10:17:02 am.
Controlled by: nter for Veterinary Biologics, 515-337-6100


Title: Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection and Compliance
Release Date: 21 May 2021 Document Number: CVB-SOP-0045.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0045.02
Page 1 of 4

Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection and
Compliance

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA
and does not imply its approval to the exclusion of other products that may be suitable.

Table of Contents
1. Purpose
2. Background

3. Definitions

4. Responsibilities

5. Procedures

6. References

7. Summary of Revisions

jon 26 May 2021, 10:17:02 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing of the APHIS Form 2( inary Biologics-Inspection and Compliance
Release Date: 21 May 2021 Document Number: CVB-SOP-0045.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0045.02
Page 2 of 4

1. Purpose

This document describes procedures for processing the APHIS Form 2007 (Form 2007),
Qualifications of Veterinary Biologics Personnel, by the Center for Veterinary Biologics-
Inspection and Compliance (CVB-IC). The Form 2007 is required by title 9, Code of Federal
Regulations (9 CFR), part 114.7(a), and is further explained in Veterinary Services
Memorandum (VSM) No. 800.63 and on the CVB Website.

2. Background

All Form 2007s should now be initially submitted to the Inspection and Compliance (IC), with
the incorporation of VSM 800.63.

Initially, a Form 2007 was submitted for each designated person at an establishment. If a
responsible person was associated with multiple establishments or permittees, a Form 2007 for
each establishment or permittee was required to be filed with CVB. For the remainder of the
standard operating procedure and applicable work instructions, the phrase “employee” will
include designated person, responsible person, authorized person, and any other reference to
Veterinary Biologics personnel. If a section applies to only one type of employee, it will be
noted.

With the implementation of the LSRTIS in October 2010, the information previously tracked in a
Microsoft Access database was migrated into LSRTIS. Each employee had a separate record for
each establishment for which they were employed. Employees that had a name change had their
record updated; however, if that employee changed either sites or establishments, a new record
was created.

In August 2014, LSRTIS 2014 was implemented. The rewrite of this environment provided an
opportunity for all records related to one employee to be combined, thereby showing a complete
history of employee’s work history related to veterinary biologics. There is one establishment
employee record and many associated establishment/site records for that employee. LSRTIS
2014 also links the employee record to the Mail Log records associated with the submission of
the Form 2007.

In April 2016, the NCAH Portal was implemented. The NCAH Portal allows the manufacturers
to enter information (including personnel data) which, if acceptable, will populate LSRTIS. This
information is utilized for their access to the Portal.

3. Definitions
2.1. BCA: Biologics Compliance Assistant
2.22 IC: Inspection and Compliance
2.3 PEL: Policy, Evaluation, and Licensing

mn 26 May 2021, 10:17:02 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100