NCAH PORTAL CVB QUICK REFERENCE

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

5

Where were changes made in the 1/17/2020 version?

1. Updates were made to eAuthentication account references

Where were changes made in the 9/13/2019 version?

1. Page 3, clarifying language was added regarding entry of data in the Product Code field

Publication Date: 10/08/2020 Page 1 of 11

Where were changes made in the 10/8/2020 version?

1. Page 6 - clarifying language and a screenshot were added for a new requirement for three Dispositions by Firm.

If the Disposition of "Other-Prelicense", "Other-Outline of Production Change" or "Other-Technology Transfer" is

selected it is now required to select a Reviewer's name. A new field with a drop down menu to select the

Reviewer's name will now appear when one of those Dispositions is chosen.
General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

Next: Entering information in the Veterinary 

Biologics Production and Test Report (APHIS 2008)

You will be taken to the Veterinary Biologics Production and Test Report Form.

1.

2.

For APHIS Form 2008 submissions, start by entering the CVB section 

of the Portal and then navigating to the 2008 Submission Form. Any user with a verified identity eAuth

account can enter 2008 information. 

Only users with the Liaison, Alternate 

Liaison, or Serial Release Role may 

submit to the CVB.

See a chart of all roles and privileges here.

NCAH PORTAL CVB QUICK REFERENCE 45

Publication Date: 10/08/2020 Page 2 of 11
SERIAL INFORMATION 

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE 5

Establishment – Only those establishments for which the employee entering the information has an APHIS Form 2007

on file for, will be available in the drop-down menu.

Site Address – The mailing address of the selected establishment will default in this box. All licensed or permitted sites are

available in the drop-down menu. The user may select either the mailing address or the site from which the 2008 was 

generated.

Product Code – A list of product codes for the selected licensee or permittee will appear. If using the type ahead feature, 

do NOT include the decimal point.

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 – Will auto-populate based on the product code.

Serial Number – Enter serial or subserial number assigned by the manufacturer. Do not include symbols.

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General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE

SERIAL INFORMATION (continued)

—–> Enter text to search “Not Selected” list. ———> Enter text to search “Selected” list. 

Select single arrow 

to move one 

selected item, and 

double arrows to 

move all items in 

search box. 

—–————————————–———–———> Select “Y” if First Serial. 

—–———————————–—–———> Select “Y” if ≤ 50 Containers. 

—–————————————–—————————————> Enter Fill Date. 

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

See VSM 800.69 or 800.213 for guidance.

5

Autogenous or Prescription Product? - Optional field if a serial or subserial is considered an autogenous product or

prescription product. Checking this box will provide the ability to enter agents for the autogenous prescription product.

It will also provide the ability to select if the serial is the first serial or if it contains less than or equal to 50

containers/vials.

Agents for Autogenous or Prescription Product - Select any agents used to make the product. Multiple agents can be selected.

Agents not available in the list should be entered in the Remarks Section. Identification of the organisms/agents should be 

sufficient for determination of causative agent for first serials, or genus and species for bacteria, fungus, and mycoplasmas; 

family for Virus for all subsequent serials.

First Serial - Select Y [yes] if the serial is a first serial made from the isolate. Autogenous first serials do not require test data to

be submitted (still follow policy in VS Memorandum 800.69, 1st serial summaries).

50 Containers - Select Y [yes] if the serial has less than or equal to 50 containers/vials produced for manufacturing purposes.

Fill Date - Enter the date the final containers were filled. If not applicable (i.e. bulk containers), leave blank.

Expiration Date - Enter the expiration date assigned to the final container. This field is mandatory for all Establishment

Dispositions except: Destroyed By Firm, File for Information, To be Reprocessed and Retested, or For Further Manufacture. 

Is this a Subserial? – Optional field to denote a serial as one of multiple subserials produced (9 CFR 101.3(i)). 

Upon this selection the “Related Subserials” field will appear. Enter each subserial that make up the total quantity of the 

completed product. This only needs to be filled out on one record (usually on the 1st or parent record).

—–————————–—————————————> Enter Expiration Date. 

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Disposi

tion by Firm – Select the applicable disposition assigned by the licensee or permittee. With many of the 

dispositions noted below, additional information is required. 

Note: Any disposition that is selected by the manufacturer may be changed by the CVB. Changes will be communicated 

back to the firm.

ESTABLISHMENT DISPOSITION 

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE



5

Establishment 

Disposition Criteria for Selecting Firm disposition 

Eligible for Release This is the default Firm Disposition for serials that have not yet been released to the 

market, but meet requirements for marketing. 

Destroyed by Firm 

Acknowledgement of an unreleased serial that has been destroyed by the firm. NOTE: It is not 

an intent to destroy. 

Destruction Reason - Select from the available list of reasons for destruction of the serial 

(i.e.unsatisfactory potency testing, unsatisfactory purity testing and other.) 

Destruction Date - Enter the actual date the destruction of the serial occurred. The date 

should not be in the future. 

Destruction Comments - Optional field for any other pertinent information. 

Reprocess & Retest 

This is used to request permission to reprocess a serial. 

Enter the new Product Code and Serial Number(s) to identify the reprocessed serial(s), as 

specified in VSM 800.62. 

Other - Expiration 

Date Correction Acknowledges the Firm’s expiration date correction. NOTE: this is not an extension of dating

Other - Extension 

of Dating 

This is used to request additional dating on remaining inventory nearing expiration, provided that 

assurances of continued potency are provided and in accordance with 9 CFR 114.14. 

On Licensed Premises? - When the "Extension of Dating" field is selected, the field “On 

Licensed Premises?” will appear within the Inventory for Release section. Select the 

check-box if the remaining inventory of the serial is on licensed premise. 

Other - File for 

Information 

Information submitted to CVB on a serial or bulk material that already has an APHIS disposition. 

It may be at the request of CVB or additional information provided by the firm. May or may not 

impact marketability of the serial. 

Other - Inventory 

Correction Acknowledges the Firm's inventory correction. 

Other - Rebottling 

This is used to request permission to rebottle a serial. 

Enter the new Product Code and the Serial Number(s) to identify the rebottled serial(s) as 

specified in VSM 800.62 and 9 CFR 114.17.

list is continued on next page

Publication Date: 10/08/2020 Page 5 of 11
ESTABLISHMENT DISPOSITION (continued)

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE

For Further Manufactured (FFM) Serials - If a serial was produced with manufacturing intermediates produced by 

another licensed manufacturer, enter the FFM Establishment Code, Product Code and Serial Number used in the 

production of the serial. The licensee or permittee number and the serial number fields will appear if the Outline of 

Production allows the option to use FFM material. If more than one FFM is used for a Serial, choose the “+” button to 

enter further information. If an option does not appear in the drop-down, enter this information in the Remarks section.



5

 Disposition by Firm – continued from previous page

Other - Subsequent 

Shipment 

Permittees utilize this disposition when a serial is brought into the United States in more than one 

shipment. Use this reason for the second or subsequent shipment when the first shipment of the 

serial has already been released. See VSM 800.101 for guidance.

Other - Transfer 

Request 

This is used to notify the CVB of a transfer of inventory from one product code to another code, 

as allowed in the filed Outline of Production. Enter the Establishment Code, Product Code and the 

Serial Number(s) to identify the new Transfer Serial(s). Processing procedures should follow 

ICWI0310. 

Other - Shorten 

Dating 

Other - For Further 

Manufacture 

Shorten Dating requests are used in instances when the virus titration result is below release; but 

above through-dating. CVB may consider release based on regulatory flexibility. 

Other - Prelicense 

**Select the Reviewer’s name that you are working with on the licensing of the product from 

the drop down list in the Reviewer field that appears when you select "Other-Prelicense"

Other - Outline of 

Production 

Change 

When a licensee or permittee is directed by their licensing reviewer to provide a serial(s) for 

confirmatory testing to support a proposed Outline of Production change, this should be chosen. 

Refer to User Guide 21.

**Select the Reviewer’s name that you are working with on the outline change from the drop down list 

in the Reviewer field that appears when you select "Other-Outline of Production Change"

Other –

Technology Transfer

When a licensee or permittee is directed by their licensing reviewer to provide a serial(s) for

confirmatory testing to support a technology transfer request, this should be chosen.

Refer to User Guide 21.

**Select the Reviewer’s name that you are working with on the outline change from the drop down list 

in the Reviewer field that appears when you select "Other-Outline of Production Change"

Establishment 

Disposition Criteria for Selecting Firm disposition 

Bulk lots that are not for release to the market, but may be sent to another manufacturer for further 

processing. 

$3+,6)RUPVIRUSUHOLFHQVHVHULDOVVKRXOGEHVXEPLWWHGSULRUWRUHTXHVWLQJDXWKRUL]DWLRQ

IURP&9%3ROLF\(YDOXDWLRQDQG/LFHQVLQJ3(/WRVXEPLWVDPSOHV6XEPLWWLQJWKHSUHOLFHQVH

VGRHVQRWJLYHDXWKRUL]DWLRQWRVXEPLWSUHOLFHQVHVHULDOVIRUWHVWLQJ<RXVKRXOGKDYHDQ

DXWKRUL]DWLRQQXPEHUIURPWKH&9%3(/WRVXEPLWSUHOLFHQVHVDPSOHV Refer to User Guide 21.

Publication Date: 10/08/2020 Page 6 of 11

**This is what the field will 

look like if a Reviewer's name 

is required based on your 

selection for Disposition by 

Firm.
TEST DATA 

Test Data File - This must be a .pdf file that contains all tests conducted by the licensee or permittee to support release

of the serial or subserial as defined in Section V of the Outline of Production. Details required on the APHIS Form 2008

should be included: Establishment #, Product Code, Serial #, Test Reference identification, date started and date

concluded, all test results, including validity and controls requirements, and the test conclusion. Also include any 

explanations for No Test and/or Inconclusive results. See VS Memorandum 800.53. Expiration date of the serial is also 

requested.

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE

NOTICE: If using a PDF fillable form, such as the fillable APHIS 2008, the user must lock or "flatten" the PDF document after 

completing the form fields to ensure that the 2008 Report generated in the NCAH Portal accurately displays the data 

entered, the document can be viewed on all devices, and to prevent other users from manipulating or editing the 

information. The document uploaded to the NCAH Portal cannot be altered once it has been uploaded; however, flattening 

the form prior to uploading will prevent any user from saving the document and editing the form fields. Follow the steps 

below to "flatten" a completed PDF fillable form:

1. Open fillable form.

2. Add appropriate data.

3. Select File.

4. Select Print.

5. Select the PDF printer. (e.g. the Adobe PDF printer is installed automatically with Adobe Acrobat)

6. Select OK.

7. Specify location on your computer/network to save the printed, "flattened" version of the form.

8. Select Save.

9. Upload the printed, "flattened" version of the form to the NCAH Portal.

5

In order to complete a submission, the test data file is mandatory for all Firm Dispositions, except: File for Information, 

For Further Manufacture, Inventory Corrections and Expiration Date Corrections. NOTE: In some instances with these 

dispositions, a test data file may be required by regulations. Always follow all applicable regulations.

The information in the test data file must be legible on the screen.

Do NOT attach anything other than Test Data. The information you attach here will be shown on Page 2 of the 2008 

Report generated by the NCAH Portal after market authorization. Click here to see an example. 

•

•

•

Select Browse to prompt a dialog box and add a file. Select Remove to delete the added file.

Publication Date: 10/08/2020 Page 7 of 11
General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE 5

Container Units - Select the unit of measure used for each serial; choose if the serial is final containers (doses), bulk 

(mL), or diagnostic test kit (units). 

# Containers - Enter the number of containers eligible for release.

Container Size - Enter the quantity in each container or tests that can be performed with each kit. For those with more

than one dose size, select the “+” button to add additional lines.

Total Doses Manufactured - When a permittee manufactures a serial internationally, the total doses manufactured

should be reported to the CVB, regardless of how much is imported into the United States in a single shipment. Those 

doses imported should be reported in the # Containers and Container Size fields in this section. 



•

•

•

•

INVENTORY FOR RELEASE 

Inventory For Release - Depending on form field selections you may have some of the following options available.

If the user selects "Autogenous, 1st Serial" in the Serial Information section, then the Inventory break down changes to 

only entering "Number of Total Doses".



Publication Date: 10/08/2020 Page 8 of 11
General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

NCAH PORTAL CVB QUICK REFERENCE 5

Letter(s) - If any supplemental information is needed to support consideration of release, attach one or more files.

This information may include bench records, or referenced letters. DO NOT ATTACH correspondence that needs 

response by the CVB other than release of serial. Multiple attachments may be uploaded in a single action.

VBI # - when testing has been conducted in response to a CVB investigation (VBI), CVB-IC will provide the VBI number (in 

the format of XX-XXX).

Related Submissions (Mail Log #) – when applicable, a mail log number (either initiated by the establishment through the 

NCAH Portal, or by the CVB- PEL or IC) may be entered here in lieu of attaching letters to the submission. Multiple mail log 

numbers may be entered.

Remarks - Include any pertinent information not captured elsewhere in the submission. However, please note special 

characters, such as the apostrophes or quotes as copied from Microsoft Word should be removed from this section 

(examples include “”, ‘, o, μ).

MISC 

*NOTE: Serials previously audited by the CVB that are being resubmitted by the licensee or permittee should

have the audit, with signature, as well as any applicable comments attached here.

Publication Date: 10/08/2020 Page 9 of 11
NCAH PORTAL CVB QUICK REFERENCE

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008) 

5

Select this button to Delete 

the submitted form.

Select this button to Submit the form to CVB. **Only those with the 

Liaison, Alternate Liaison or Serial Release role will see this button.

Select this button to Clone 

the submitted form.

REVIEWING YOUR ENTRY

Select this button to Edit the submitted form.

**You can only Edit if CVB has not received the form.

CLONING 

Cloning - Cloning allows the user to copy fields from the submission form. Fields that are copied include: Product

Code, Fill Date, Expiration Date, Disposition by Firm, and Remarks.

Go to the next page to see how to submit multiple 2008s to the CVB.

Publication Date: 10/08/2020 Page 10 of 11
NCAH PORTAL CVB QUICK REFERENCE 5

Any 2008 records may be submitted together. Each record will be reviewed and processed individually at the CVB. Select 

any record’s check box, and then click Submit to CVB. At this point a record cannot be edited or deleted. If there are 

discrepancies found, contact the CVB for the record to be audited (if not processed already). 

To view status updates including the assigned APHIS Disposition, when a 2008 is on Test or if 

the 2008 has been completed, see your Submission History (CVB) page in the NCAH Portal. 

Click here to see the Submission History (CVB) and Account Details User Guide.

General Guide for Veterinary Biologics Production and Test Report (APHIS 2008)

Click each box to

select that item

for submission

You can sort the columns

by clicking on the arrows

or the column headers.

Submitting Multiple 2008s to the CVB

To submit 2008s directly to the CVB, click 'View Draft Submissions (APHIS Form 2008 to CVB)' on the Dashboard.

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