An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-15

TO: Biologics Licensees, Permittees, and Applicants 

Directors, Center for Veterinary Biologics 

Veterinary Services Leadership Team 

FROM: Byron E. Rippke 

Director 

SUBJECT: Implementation of Single Label Claim and Labeling/Packaging Rules

I. PURPOSE

The purpose of this notice is to announce procedures for implementation of the 

Single Label Claim and Labeling/Packaging Rules recently published as final rules 

in the Federal Register.

II. BACKGROUND

APHIS Rule 2011-0049 (Single Label Claim for Veterinary Biological Products) 

was published July 10, 2015, to provide a simpler labeling format that would better 

communicate product performance to the user. It also requires publication of a 

standardized summary of the efficacy and safety data submitted to the Animal and 

Plant Health Inspection Service in support of product licensure. The Center for 

Veterinary Biologics (CVB) elected to delay implementation of the Single Label 

Claim rule until companion docket APHIS 2008-0008, which would also require 

labeling updates, was finalized.

APHIS Rule 2008-008 (Labeling and Packaging), published August 29, 2016, 

updates numerous requirements for label content and packaging requirements. The 

implementation date for this rule is October 31, 2016. Because the two rules are 

now final, the CVB will begin coordinated implementation of both rules.

III. ACTION

Licensees, permittees, and applicants should refer to the Single Tier Label Claim 

(STLC) Industry Guidance page of the CVB website. This page contains detailed 

instructions on preparing standardized summaries of efficacy and safety data as 

well as numerous examples. Individuals wishing more assistance may send 

questions or a request for a teleconference to cvb.single.tier@aphis.usda.gov.

Veterinary Services Memorandum No. 800.54, Guidelines for the Preparation and 

Review of Labeling Materials, will be updated and a Draft for Comment posted to 

the CVB website prior to October 31, 2016. The revised memorandum will provide 

guidance related to the Labeling and Packaging rule.

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. 16-15

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IV. IMPLEMENTATION/APPLICABILITY

The Single Tier Label Claim rule applies to vaccines, bacterins, toxoids, and 

immunomodulators. Products exempted from this rule include antibody products,

diagnostic test kits, autogenous or prescription products, and allergenic extracts.

The Labeling and Packaging rule applies to all products.

Licensees and permittees may voluntarily comply with the provisions of both rules for 

products initially licensed prior to October 31, 2016. Labeling for products initially 

licensed after that date must be in compliance with both rules.

Labeling for products licensed with 4-tier language, rather than a single tier claim, will be 

transitioned over a 4-year period, beginning October 31, 2016. Details of the timeline are 

found on the STLC Industry Guidance page of the CVB website.