NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE

Biologics Sample Submissions - (APHIS 2020) "Routine Samples"

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Where were changes made in the 10/21/2020 version?

1. Page 4, when "Resubmission" is selected for the Purpose, the Sample Code field is now required to be filled 

Publication Date: 10/21/2020 Page 1 of 5
NCAH PORTAL CVB QUICK REFERENCE GUIDE

Biologics Sample Submissions - (APHIS 2020) “Routine Samples”

Only users with the 

Sampler Role 

can enter sample information 

and generate Packing Slips to be 

shipped with samples.

For all types of sample submissions, start by entering the 

CVB section of the NCAH Portal and then navigating to the

Sample Submission Form.

You will be taken to the Biologics Sample Submission Form.

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Publication Date: 10/21/2020 Page 2 of 5
NCAH PORTAL CVB QUICK REFERENCE GUIDE

Biologics Sample Submissions - (APHIS 2020) “Routine Samples”

————————————————————————> Not needed for Routine Samples.

->Select from drop-down menu, if different from default.

->Select from drop-down menu, if different from default.

—————————————————————————> Select from drop-down menu.

——————> This field will be auto-populated based on the selected Product Code. 

——> Enter Serial Number, 20 alphanumeric characters only—NO SYMBOLS. 

Fields with a red asterisk (*) are required. 

Establishment – This list is populated by the active manufacturers the user is assigned to within the CVB 

database. 

Product Code – Select from the list of all available product codes for the manufacturer if not auto-populated.

NOTE: Any product code, ever assigned to your firm will be listed here in an effort to make the system flexible to users' needs

and situations (like information needed on a Destroyed serial for one that was recently terminated, or if there was a firm

merger).

Product Name – This field will auto-populate based upon the selected product code.

Serial Number – This field is free text, however, the serial number listed here must match the Form 2008 submission

exactly, or the records will not match up. Do not enter symbols. 

Continued: Submitting Routine Samples

Auth Number – This field is for the STR (Special Request authorization number) assigned by 

the CVB. For entry of samples for STR Auth Numbers, see the User Manual for 

Sample Entry for a Special Test Request. 

Serial Information

Site Address – Defaulted to manufacturer's mailing address; however, this can be the address from where the samples are 

being shipped. All licensed sites will appear in the drop down list for domestic manufacturers.

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Publication Date: 10/21/2020 Page 3 of 5
NCAH PORTAL CVB QUICK REFERENCE GUIDE

Biologics Sample Submissions - (APHIS 2020) “Routine Samples”

—————————————————————————————————> Check the box if applicable. 

———————————————————> Select from drop-down menu. 

Enter Number of Containers and Amount Per Container. Select from drop-down menu. 

—————————————–—> Enter if the sample is either Bulk or Final.

Purpose – 

• Select "Routine" when submitting routine post-license samples to the CVB that will be eligible to be selected for

confirmatory (check) testing. Also, use this purpose when submitting samples that had previously been rejected by

CVB.

• Select "Resubmission" when submitting samples of any serial or master seed or cell that has previously been

submitted to the CVB for any reason.

• Select "Pre-license" when submitting samples for pre-license testing.

Sample Code – this field will only appear when "Resubmission" is selected for the Purpose. You will be required to enter 

a sample code when using this purpose; contact the CVB if you don't know the sample code to use. If testing was initiated 

by the CVB on routine testing, but more samples are needed to finish the testing, the CVB will contact the firm to request 

more samples to be resubmitted.

Subserial – Indicate if the serial is considered a subserial by the manufacturer. 

Packaged Shipped With – Samples shall be kept under refrigeration at 35°- 45°F (2°-7°C) unless otherwise specified in the 

approved Outline of Production (9 CFR 114.11).

Size: Number of Containers – See VSM 800.59 for guidance (9 CFR 113.3)

Sample Type – Final samples should be submitted in most cases, unless directed by the CVB.

Contains Thimerosal? – Utilize this check box if the product contains Thimerosal.

——————————————–———> Check the box if the sample has Thimerosal or Merthiolate.

Sample Information - Routine

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Amount Per Container – The number of doses/mLs (FILLED in each container) or Units (number of test kits). If the 

manufacturer has authorization for partial-fills (see VSM 800.206), a final container label used on the retention samples 

may not match the actual fill volume. In these cases, notate in the Remarks section the volume and doses/tests.

If more than one sample size is submitted, use the smallest volume for entry. However, multiple dose sizes submitted 

should be entered into the Remarks Section.

If the volume is less than 1 unit, round the number up to 1. If the volume is not a whole number, but is greater than 1 

(i.e. 10.5 mL), round down to the nearest whole number.

Type – Label designating Doses, mL, Units. For diagnostic test kits, use units. 

Publication Date: 10/21/2020 Page 4 of 5
NCAH PORTAL CVB QUICK REFERENCE GUIDE

Biologics Sample Submissions - (APHIS 2020) “Routine Samples”

Remarks – Enter any applicable information not contained in the above fields. (i.e. who requested 

the resubmission of samples, additional doses sizes submitted to CVB).

Save—Upon saving, the record must be printed as a Packing Slip and submitted to the CVB with the sample

packaging. 

—> Check box once complete. 

—————————————————————————————> Select button to Save form. 

Misc.

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Select to Clone 

the submitted form.

After saving the submission, you will be directed to the Shipment and Receipt Page.

Select to Delete the submitted form. The record may be 

deleted until it has been received by the CVB. 

*If a record needs any corrections, it must be deleted and

re-entered completely.

CLONING

Cloning - Cloning allows the user to copy 

fields from the submission form. Fields that are copied include: Product 

Code, Purpose, Shipment with Type, Number of Containers, Amount Per Container, Dose Type, Sample Type, 

Containing Thimerosal, and Remarks. 

For guidance on submitting the sample to CVB, see the User Manual for

Generating a Packing Slip for Shipment of Samples.

SUBMITTING THE SAMPLES TO CVB

Publication Date: 10/21/2020 Page 5 of 5