An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-03

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Expanded NCAH Portal Functionality: Electronic Outlines of 

Production and Special Outlines

I. PURPOSE

The purpose of this Notice is to inform licensees, permittees, and applicants that the 

Center for Veterinary Biologics (CVB) is expanding the functionality of the webbased NCAH Portal by adding to the types of submissions that can be accepted. 

Outlines of Production and Special Outlines are being added as new submission 

types under APHIS Form 2049. Submitters must be portal-enabled to submit 

electronic Outlines. 

II. BACKGROUND

The NCAH Portal is external-facing and enables web-based electronic submissions 

and responses between biologics firms and the CVB. To date, all submissions to the 

CVB’s Policy, Evaluation, and Licensing unit (PEL) except Outlines have been 

accepted via the NCAH Portal. This expansion completes the PEL transition from 

paper submissions; upon implementation, all PEL submissions may be submitted 

electronically via the Portal.

III. ACTION 

A. Portal-Specific Format and Submission Process Required

The procedure for submitting and reviewing electronic Outlines is substantially 

different from the traditional paper process. It will leverage efficiencies of 

electronic document comparison and facilitate document navigation. Therefore it 

is essential to submit Outlines in the proper electronic format. 

Before submitting an electronic Outline, read the following instructions:

• User Guide 17—Template Requirements for Electronic Outlines

• User Guide 18---Creating and Revising Electronic Outlines

• User Guide 19—Versioning Electronic Outlines

• User Guide 20—Submitting Outlines to Policy, Evaluation, and Licensing 

via the NCAH Portal

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-03

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 An Equal Opportunity Provider and Employer

The procedure includes:

• Document preparation on CVB-approved template with navigable 

headings

• Establishment of a “baseline” electronic version from which future 

revisions may be compared. A baseline must be identical in content to the 

most recent paper Outline and file with the CVB. A baseline must be on 

file at the CVB before Outline content is revised.

• The same MS Word document will be repeatedly exchanged between the 

firm and the CVB, with current changes tracked, as revisions are 

warranted.

Companion videos for each of these User Guides are also available on the NCAH 

Portal Guidance page of the CVB website. 

Direct any additional questions to CVB.PIMS@aphis.usda.gov. 

B. Staged Submissions

The CVB anticipates a substantial influx of submissions as firms file their 

Baseline versions of electronic Outlines. Please submit only one electronic 

Outline until the CVB has confirmed that the document format and submission 

details are correct.

Once an initial electronic Outline has been processed by the CVB, please limit 

electronic Outline submissions for your firm so that there are no more than 10 

pending review by the CVB at any given time. The CVB plans to assign extra 

personnel to process Baseline versions, but it will take time to convert all Outlines 

to electronic format industry wide. Assistance in providing a manageable 

submission flow is appreciated.

IV. IMPLEMENTATION/ APPLICABILITY

Detailed procedural instructions and companion training videos are available 

immediately on the NCAH Portal Guidance page of the CVB website. Users are 

expected to read and understand User Guides 17 through 20 prior to submitting 

electronic Outlines. 

The NCAH Portal will be updated to accept electronic Outlines on March 16, 2017. 

Notification of the exact date will be posted to the CVB’s NCAH Portal Guidance web 

page. Outlines not submitted according to the User Guides will be closed out in the 

NCAH Portal without review, with a note to resubmit in the proper manner. 
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-03

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 An Equal Opportunity Provider and Employer

Submit only one electronic Outline at first. Once that Outline has been processed 

successfully by the CVB, it is permissible to submit additional electronic Outlines at

reasonably spaced intervals. 

The CVB will continue to process paper Outlines for those products that do not yet have 

an electronic baseline document on file with the CVB, but once converted to electronic 

format, only electronic revisions will be accepted.