Receiving and Updating Establishment Personnel Data

CONTROLLED//PROPIN//BASIC

CVB-WI-0086.05 

Issue Date: 13Jun23 Page 1 of 9 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

Source Document: Veterinary Services Memorandum No. 800.63, Personnel at Licensed Establishments 

Background - See current version of CVB-SOP-0045, Processing of the APHIS Form 2007 by 

the Center for Veterinary Biologics-Inspection and Compliance (CVB-IC). I. Receipt of APHIS Form 2007 (Form 2007) through the NCAH Portal (see Appendix I)

A. Receipt:

All Form 2007s are received by the CVB-IC. If Form 2007s are received by the CVBPolicy, Evaluation and Licensing (PEL), in the case of establishments in the prelicensing 

phase, Hard Copies are given to the CVB-IC for initiation of the workflow. 

No Mail Logs (ML) for Form 2007s will be initiated by the CVB-PEL. If a Form 2007 is 

received from the firm via the NCAH Portal 2049s, this will be returned to the firm and 

instructed to re-enter into the Form 2007 module of the NCAH Portal. 

If a submission is received from the NCAH Portal, the submission will be automatically 

routed to the CVB-IC Inbox in ML. This inbox should be monitored daily. The Biologics 

Compliance Assistant (BCA) assigned to the firm will “self-assign” the ML item for 

further processing. 

B. BCA Review (Review of Form 2007 for sufficiency) 

1. Is the form Complete and accurate? 

Fields that must be filled out: Name, Est #, Site Address, Title, Year 

Employed

If acceptable, go on to Step B.2.

If it is unacceptable, return to the firm with Approval set to “No”, and enter 

the reason(s) in the Remarks. The close the ML select Workflow Completed, 

No Records Management. 

2. The BCA should search for the employee’s record (either with the same firm or a 

different firm). See Section C if applicable. If a record is found to be an exact match that is inactive, the records should be 

linked. 

If a record is found, with another active firm, discussion with the IC 

management team should be held to determine if shared employee status is 

permissible. Letters should be on file with both establishments if there is not 

license documentation on file (APHIS Form 2001 or 2003). 

If a record is found, within the same firm, these may be returned unprocessed 

for the firm to resubmit as a “Modify” or “Reactivate” Form 2007. See NCAH 

Portal guidance, Qualifications of Veterinary Biologics Personnel, Guide # 4.

3. Is the submission requesting for an employee to be a Liaison or Alternate? 

A Child loop to the Reviewer should be initiated (Liaison Approval Request). 
Receiving and Updating Establishment Personnel Data

CONTROLLED//PROPIN//BASIC

CVB-WI-0086.05 

Issue Date: 13Jun23 Page 2 of 9 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

The Reviewer will review and Approve or Deny within the ML (if initiated 

from the NCAH Portal), with Response “Acknowledged by <name>” or if 

denied, state reason in the Response. This is done by Editing the ML record. 

Move on to Step 7. 

4. Is the submission inactivating a Liaison or Alternate? 

A Child loop to the Reviewer should be initiated (Liaison Approval Request). 

The Reviewer will NOT have to Approve or Deny within the ML as this 

automatically is set to Approve (YES). 

Move on to Step 7. 

5. Is the submission inactivating other than Liaison or Alternate? 

Move on to Step C. Finalization. 

6. Is the submission requesting for an employee to be a Sampler?

The ML should be submitted to the Specialist. 

The Specialist will review and Approve or Deny within the ML (if initiated 

from the NCAH Portal), by Editing ML and entering in the Approval area: 

item #xxxxxx, with Response “Acknowledged by <name>” or if denied, state 

the reason in the Response. 

o If Denying – confer with the IC Section Leaders first.

The request from the firm should have documentation attached that the 

employee had been trained in accordance with Veterinary Services 

Memorandum (VSM) No. 800.59. 

7. All other Form 2007s 

The ML should be routed to the Specialist. 

The Specialist should then review the information for completeness and 

validity of the Form 2007. 

The Specialist will review and Approve or Deny within the ML (if initiated 

from the NCAH Portal), by Editing Mail Log item #xxxxxx; no response is 

needed unless the Form 2007 is denied. 

o If Denying for reasons other than format of submission – confer with 

the IC Section Leaders first.

8. The Specialist will then return the Form 2007/ML to the BCA under the ML action of 

“Finalization” for entry into LSRTIS. 

C. Finalization

1. New Form 2007: These Form 2007s may now be automatically updated (as of 

September 2016). 

Receiving and Updating Establishment Personnel Data

CONTROLLED//PROPIN//BASIC

CVB-WI-0086.05 

Issue Date: 13Jun23 Page 4 of 9 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

CVB-TEM-0039, Liaison/Alternate Approval Letter and upload into the ML item

and add to the ML item.

A Child loop to the Reviewer will be initiated (Liaison Approval Request). 

The Reviewer will review and Approve or Deny by accepting the letter as is or redrafting the letter with their response.

Upon Finalizing the ML, the BCA will obtain the Specialist’s signature and mail 

the letter to the firm.

2. Is the submission inactivating a Liaison or Alternate Liaison? 

A Child loop to the Reviewer (Liaison Approval Request). 

The Reviewer will NOT have to Approve or Deny the request unless they take 

exception with the request.

3. Is the submission requesting for an employee to be a Sampler? 

The ML is submitted to the Specialist. 

The Specialist will review and Approve or Deny by drafting a Sampler request 

letter. Requests for Sampler authorization must be granted by the Specialist prior 

to LSRTIS entry. The most current version of 

CVB-TEM-0028, Sample Authorization Letter, should be utilized. 

The request should have documentation that the employee had been trained in 

accordance with VSM 800.59. 

4. All other Form 2007s 

The ML should be routed to the Specialist. 

The Specialist should then review the information for completeness and validity 

of the Form 2007. 

The Specialist will review the Form 2007 and initial/date the HCs. 

o If the Specialist returns the Form 2007 unprocessed, the reason must be 

documented in a letter 

o The only field that may be filled in or corrected by the Specialist or BCA 

is Block 1.D, Establishment (Est.) License Number. This is usually only 

required for prelicensing firms. 

o If the firm is reporting other types of changes to its personnel roster, the 

Specialist reviews the Form 2007 and/or organizational chart. If it is 

acceptable, a response letter is not required. The Specialist initials the top 

right-hand corner of the organizational chart and returns the submission to 

the appropriate BCA. The Specialist initials and dates Box 6 on the Form 

2007. 

5. The Specialist will then return the Form 2007/ML to the BCA under the ML action of 

Finalization for entry into LSRTIS. 

Receiving and Updating Establishment Personnel Data

CONTROLLED//PROPIN//BASIC

CVB-WI-0086.05 

Issue Date: 13Jun23 Page 6 of 9 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

2. Fill in Establishment, Site, Year Employed at Firm, Job Title, Most Recent Form 

2007 Date (date signed by employee), ML Item and Add Roles

3. Click on “ Create”

E. To Remove/Inactivate Establishments:

1. Under Establishment/Roles, click on “Show” for the correct Est. number 

2. Click on Edit and unmark “Active” box

3. Click on “ Update”

F. To Inactivate Employee (if only assigned to one firm): 

In the Show Establishment Employee screen, click “Inactivate” at the bottom of the 

screen. This will inactivate both the employee and their associated establishment/roles.

G. To verify any of the actions above, click on the Employee’s name (within the blue box) 

and verify that the actions taken match the information on the Form 2007 and 

correspondence. 

H. New Employee: After running the “Establishment Employee Search” report and verifying 

that the employee is not in LSRTIS, follow the directions below. 

1. Click on the “Create Establishment Employee” link on the top left of the page

2. Enter Establishment Employee Info to include comments 

3. Enter Establishment Employee Contact Info, if applicable 

4. Enter Establishment Employee Education Info

5. Click “Create” 

6. Under Establishment/Roles (last category of the page) click the link “Add New 

Site/Role”

7. Enter the Establishment information to include ML #. If there is a role, remember to 

click “+Add Role” after you have selected the role. 

To verify information, follow steps in Section II.G. 

IV. Filing

A. No HC files will be maintained for the NCAH Portal submissions. 

B. HC Files – not the NCAH Portal submissions

1. Superseded Form 2007: If the Form 2007 supersedes a Form 2007 currently on file, the 

BCA removes the superseded Form 2007 from the Active Personnel file. The BCA marks 

through it with a diagonal line and labels it as “Superseded,” along with their initials and 

date. The BCA then staples the superseded Form 2007 to the cover letter and files this 

packet in the Personnel Correspondence file for the firm.

2. Obsolete Form 2007: The BCA removes the obsolete Form 2007 from the Active 

Personnel file. The BCA marks through the Form 2007 with a diagonal line and labels it 

as “Obsolete,” along with their initials and date. The BCA then staples the obsolete Form 
Receiving and Updating Establishment Personnel Data

CONTROLLED//PROPIN//BASIC

CVB-WI-0086.05 

Issue Date: 13Jun23 Page 7 of 9 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

2007 to the cover letter and files this packet in the Personnel Correspondence file for the 

firm.

C. General information regarding filing of HC Form 2007 

1. The BCA files the Form 2007 in the firm’s Active Personnel file in alphabetical 

order. 

2. Approved Sampler: Files the yellow file copy of the Sampler authorization letter in 

the Personnel Correspondence file.

3. Files organizational charts, if submitted, in the Personnel Correspondence file. 

V. Consultants for Licensed Manufacturers 

A. When a firm representative has submitted official correspondence allowing a consultant 

to be able to communicate to the CVB on behalf of the firm, the CVB should file this 

information within the ML. 

PEL Reviewers should tag this correspondence as “Authorized Consultant.”